MenorrhagiaAQTH-EA-FCS-26NCT07925008
Clinical Study on the Safety and the Performance of an Endometrial Ablation System in Women With Abnormal Uterine Bleeding (AUB) and Previous Cesarean Delivery.
A study testing Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in people with Menorrhagia, run by Aqua Therapeutics, Inc. at 2 sites in 2 countries.
Trial summary
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss. Chronic AUB refers to irregularities in menstrual bleeding for most of the previous 6 months. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed participant informed consent form (ICF).
- Females aged ≥ 30 years and ≤ 55 years at baseline with no desire to conceive, with or without simple endometrial hyperplasia (without atypia) and with a history of cesarean section.
- Diagnosis of AUB.
- Documented premenopausal status (follicle-stimulating hormone (FSH) level ≤ 40 mIU/mL), women who don't want to receive hormonal treatment or who have failed to respond to hormonal treatment.
- Pictorial Blood Loss Assessment Chart (PBAC) score ≥150 at baseline.
- Normal endometrial biopsy.
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- Negative PAP test.
- Willingness to follow all study procedures, including attending all site visits, tests, and examinations.
- Willingness to avoid the use of vaginal ring, hormonal intrauterine device (concomitant IUD such as Essure is not allowed prior to the ATTTVAS Ablation Treatment), oral contraceptives during the study period.
Who cannot join
- BMI ≥40
- Postmenopausal status.
- Undiagnosed vaginal bleeding.
- Cesarean scar defect which in the opinion of the Investigator is contraindicating endometrial ablation.
- A participant with a history of a prior completed endometrial ablation procedure and/or endometrial resection including endometrial ablation/resection performed immediately (between the screening visit and the EA procedure) prior to the ATTTVAS ablation treatment regardless of the modality by which it was performed.
- Uterine cavity-length is <4 and >6.4 cm (without cervix length).
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- Pregnant or breastfeeding.
- Less than 1-year post-partum.
- Any contraindication to endometrial ablation.
- History of abortion (including spontaneous/incomplete) within 8 weeks before the study treatment (6 weeks is acceptable if transvaginal ultrasound confirms uterus normalization).
- History of previous transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior (between the screening visit and the EA procedure) to the ATTTVAS ablation treatment.
- Documented or suspected pelvic inflammatory disease, active/acute endometritis, sexually transmitted disease, bacteremia, sepsis, other active local and/or systemic infections.
- Documented active genital or urinary tract infection (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis) at the time of treatment.
- Congenital malformations of the female genital tract or of the uterus, fibroid(s) distorting the uterine cavity, or large (> 1 cm) endometrial polyp(s).
- Subjects with suspected or known coagulopathies or currently receiving anticoagulation therapy.
- Participants currently on medications that could thin the myometrial muscle, such as long-term steroid use (except for inhaler or nasal therapy for asthma).
- Documented cervical dysplasia, complex or atypical endometrial hyperplasia, abdominal or pelvic cancer.
- Presence of any relevant severe organic, systemic, or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that in the opinion of the Investigator may interfere with the participation to the study.
- Active malignant neoplasm of any type, or history of malignancies (participants with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are acceptable).
- Participation in another investigational study within 30 days before the study treatment.
- Recent history (past 6 months) or suspicion of alcohol abuse or drug addiction.
- Inability to follow study procedures.
- History of allergic reactions to any components used in the sedation protocol at the site.
- -
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Akademisches Lehrkrankenhaus Feldkirch
Feldkirch
Burghard Abendstein, Burghard.Abendstein@lkhf.at
Burghard Abendstein, MD
Italy1 site, 1 recruiting
- Recruiting
U.O.C. Ginecologia Oncologica
Roma
Ursula Catena, MD
About this study
Official title: A Pre-Market, Traditional Feasibility, Pilot, Interventional, Clinical Investigation to Evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women With Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss. Chronic AUB refers to irregularities in menstrual bleeding for most of the previous 6 months.
AUB can be frequent or infrequent, prolonged, irregular, or heavy. Heavy menstrual bleeding (HMB) is defined as "excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life". Causes of AUB are classified as polyps, adenomyosis, leiomyomas (AUB-L), malignancy and premalignant conditions, coagulopathy, ovulatory disorders (AUB-O), endometrial disorders (AUB-E), iatrogenic, and 'not classified ' . AUB affects approximately one in four women between 30 and 50 years of age, with serious implications on woman's quality of life (QoL). Endometrial ablation (EA) is a uterus-preserving procedure that aims to destroy or remove the endometrial tissue in selected women who have no desire for future fertility. EA has become an alternative to hysterectomy in the treatment of AUB because it is less invasive and has a shorter recovery period. At present, many different techniques are available to remove the endometrial tissue. Resectoscopic endometrial ablation (REA) consists of targeted endometrial destruction under direct hysteroscopic visualization. REA techniques include endometrial laser ablation, transcervical resection of the endometrium, and rollerball endometrial ablation. Non-resectoscopic endometrial ablation (NREA) uses a variety of energy sources to non-selectively destroy the endometrial lining and include thermal balloon endometrial ablation, microwave endometrial ablation, hydrothermal ablation, bipolar radiofrequency endometrial ablation, endometrial cryotherapy, and more recently vapor endometrial ablation. NREA technologies require short surgical time and can also be performed in the outpatient setting. Vapor EA is one of the newest approaches in the field. In this context, the Aqua Therapeutics Thermal Therapy Vapor Ablation system (ATTTVAS; AQUA Therapeutics Inc.) is a novel system designed to ablate uterine tissue using vapor thermal therapy technology. The ATTTVAS is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. In this Pre-Market, Traditional Feasibility, Pilot, Interventional, Clinical Investigation we aim to evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women with Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
Read the detailed description
The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is a system designed to ablate uterine tissue by vapor thermal therapy technology. The ATTTVAS consists of a reusable Generator, a DISPOSABLE APPLICATOR, a DISPOSABLE CATHETER and a SYRINGE. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well. For each participant enrolled, a total of 7 visits (5 on-site and 2 remote) will be planned according to the flowchart. One unscheduled visit can be planned on-site according to Principal Investigator's judgement between V2 and V5/EOS visits. If the Investigator can complete all the assessments foreseen at baseline visit (V0) and V1-EA in one day, V0 and V1 may coincide.
Each participant, after signing the Informed Consent Form (ICF), will enter a screening phase (V-1) during which several assessments (e.g., demographics, medical history, current menstrual condition, blood analysis) will be conducted. At the screening visit, the participants will receive a menstrual calendar and a PBAC to be completed. The PBAC score must be recorded as soon as available to confirm that the subject can be enrolled at baseline (PBAC must be ≥150). The PBAC score will also be recorded at the EOS visit. At baseline (V0) and at EOS, on site, the participants will also complete the Menorrhagia Impact Questionnaire (MIQ). At V1, the enrolled participants will undergo EA with the ATTTVAS. EA must be performed within 15-20 days from the beginning of the menstrual cycle. EA cannot be performed in the presence of heavy menstrual bleeding, but it can be performed in the presence of light bleeding/spotting. Sedation will be performed before EA as per clinical practice. The duration (seconds) of the ablation cycle (the treatment typically runs for 90 seconds) will be recorded on the CRF. After the procedure is completed, the PI will fill in a questionnaire on procedural ease of use. Device deficiencies (if any) will be recorded. At discharge, after 24 hours and 1 week from discharge, the participants will be asked to rate pain intensity on a Numeric Rating Scale (NRS). At discharge, the participants will receive a diary, to record AEs and concomitant medications, a PBAC and a menstrual calendar to be completed during the study period. Satisfaction with the procedure will be evaluated using a 5-Likert Scale (completed by the PI and the participants) at discharge and EOS visits. Gynecological examination and vital signs monitoring will be performed at applicable visits (see flowchart). AEs, concomitant medications and current menstrual condition will be monitored during the entire study period. To evaluate the need for surgical or medical intervention to treat AUB after EA, any surgical or medical intervention required to treat AUB after EA will be recorded during the study.
A Data and Safety Monitoring Board (DSMB), appointed by the Sponsor, will review the adverse events reported in the study and make recommendations to the Sponsor regarding any actions (continue, suspend, modify, or stop the clinical investigation) to be taken. For safety reasons, the first DSMB meeting will be triggered after the occurrence of 5 SADEs related to the ATTTVAS (if any).
- Conditions
- Menorrhagia
- Being tested
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)Device
The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. The ATTTVAS is intended to be used by qualified healthcare professionals specifically trained in the field of endometrial ablation. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) medical device | Experimental | All Patients shall be screened for initial study eligibility by the Principal Investigator at the investigational site. Potential candidates, that according to the investigator judgment should be treated with IP, will be identified, with the assessment of their eligibility criteria, by the study site Principal Investigator and research staff. Patients will be considered to be enrolled in the study once they have met all of the inclusion and none of the exclusion criteria. Patients who do not meet the criteria will not be enrolled in the study. The patient involvement in the study will last until the EOS visit. Receives: Device: Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.
The event, date of onset, severity, duration, and relationship to the device will be recorded. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.
Measured: V-1(within40 days before baseline);V0 (baseline); V1 (day 2, EndoAblation_discharge)V2(phone call after 24hours after discharge);V3(1week after V1)V4(6 weeks afterV1);unscheduled visit (betweenV2 andV5);V5(12weeksAfterDischarge)
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital sign.
Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg)
Measured: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs.
Safety will be monitored through Heart Rate measurement. Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm)
Measured: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs.
Safety will be monitored through measurement of the oxygen levels. 2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood. The measurement of O2 is performed using a non-invasive device known as a pulse oximeter.
Measured: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data
Blood analyses will include:
Hemoglobin g/dL
Measured: V-1 (within 40 days before baseline); V5 (12 weeks after V1)
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data
Blood analyses will include:
- Hematology: complete blood count (including red blood cell count, white blood cell count, platelet count)
Measured: V-1 (within 40 days before baseline); V5 (12 weeks after V1)
Secondary outcomes (9)
To evaluate the performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) by assessing the change in menstrual blood loss during the study, as measured by the Pictorial Blood Loss Assessment Chart (PBAC) score.
PBAC is a visual tool used to estimate menstrual blood loss. The PBAC uses a set of pictures that represent different levels of blood flow during menstruation. Users compare their own blood flow to the pictures to estimate their menstrual blood loss.
The patients should record the number of tampons and sanitary pads used each day during the bleeding episode by placing the number under the day and next to the box representing the amount of bleeding each time the patient change pad or tampon. The patients should Record clots by indicating whether they are the size of a coin in the small and large blood clot row under the appropriate day
Measured: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate the effect of menstrual blood loss on the quality of life
To evaluate the effect of menstrual blood loss on the quality of life, the Menorrhagia Impact Questionnaire (MIQ) will be completed by patients. MIQ is instrument for Bleeding-specific symptom and quality of life that measures impact of heavy menstrual bleeding with six items total on perceived amount of blood lost, impact on work, impact on physical activities, social activities, number of activities limited, and perceived impact of treatment on symptoms. Total MIQ score range: 4 to 21. Higher scores indicate a worse menorrhagia-related quality of life, meaning greater perceived menstrual blood loss and greater interference with daily, social, physical, and work activities.
Measured: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate pain intensity after treatment
To evaluate pain intensity after treatment, a Numeric Rating Scale (NRS) - with 0 representing no pain and 10 representing unbearable pain will be used.
Measured: V1 (day 2, at discharge); V2(phone call after 24hours after discharge);V3(1week after V1)
To evaluate procedure difficulty
To evaluate the procedural ease of use, a questionnaire will be completed by the Investigator on the day of treatment. The PI will compile a multiple choice questionnaire and answer to some questions on procedural ease of use.
Measured: V1 (day 2, at Endometrial Ablation)
To evaluate menstrual changes (menstrual frequency).
To monitor menstrual changes (menstrual frequency), a menstrual calendar will be used by the patient.
Menstrual frequency is the length of the menstrual cycle, measured as the number of days between the first day of one menstrual period and the first day of the subsequent menstrual period.
Measured: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate menstrual changes (menstrual duration).
To monitor menstrual changes (menstrual duration), a menstrual calendar will be used by the patient. Menstrual duration is the number of days of menstrual bleeding during a menstrual cycle, measured from the first day of menstrual bleeding to the last day of bleeding of the same menstrual period.
Measured: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate menstrual changes (menstrual regularity).
To monitor menstrual changes (menstrual regularity), a menstrual calendar will be used by the patient. Menstrual regularity is defined as the consistency with which menstrual cycles occur at predictable intervals over time. It is assessed based on the variability in cycle length between consecutive menstrual cycles. The unit of measure is categorical (Regular/Irregular).
Measured: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate patient's satisfaction with the ATTTVAS.
To evaluate patient's satisfaction with the ATTTVAS, a 5-Likert Scale will be used. Here's a breakdown of a typical 5-point Likert scale:
Strongly Disagree Disagree Neutral (or Neither Agree nor Disagree) Agree Strongly Agree This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze.
Measured: V1 (day 2, at discharge) V5(12 weeksAfterDischarge)
To evaluate PI's satisfaction with the ATTTVAS.
To evaluate PI's satisfaction with the ATTTVAS, a 5-Likert Scale will be used. Here's a breakdown of a typical 5-point Likert scale:
Strongly Disagree Disagree Neutral (or Neither Agree nor Disagree) Agree Strongly Agree This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze.
Measured: V1 (day 2, at Endometrial Ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start30 Jul 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- this is a A Pre-Market, Traditional Feasibility, Pilot, Interventional, Clinical Investigation to Evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women with Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aqua Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925008
- Sponsor's protocol ID
- AQTH-EA-FCS-26
- Acronym
- AQTH-EA-FCS-26
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Market, Traditional Feasibility, Pilot, Interventional, Clinical Investigation to Evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women With Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
- ClinicalTrials.gov ID
- NCT07925008
- Acronym / sponsor ID
- AQTH-EA-FCS-26 / AQTH-EA-FCS-26
- Conditions
- Menorrhagia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aqua Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss. Chronic AUB refers to irregularities in menstrual bleeding for most of the previous 6 months.
AUB can be frequent or infrequent, prolonged, irregular, or heavy. Heavy menstrual bleeding (HMB) is defined as "excessive menstrual blood loss which interferes with a woman's physical, social, emotional and/or material quality of life". Causes of AUB are classified as polyps, adenomyosis, leiomyomas (AUB-L), malignancy and premalignant conditions, coagulopathy, ovulatory disorders (AUB-O), endometrial disorders (AUB-E), iatrogenic, and 'not classified ' . AUB affects approximately one in four women between 30 and 50 years of age, with serious implications on woman's quality of life (QoL). Endometrial ablation (EA) is a uterus-preserving procedure that aims to destroy or remove the endometrial tissue in selected women who have no desire for future fertility. EA has become an alternative to hysterectomy in the treatment of AUB because it is less invasive and has a shorter recovery period. At present, many different techniques are available to remove the endometrial tissue. Resectoscopic endometrial ablation (REA) consists of targeted endometrial destruction under direct hysteroscopic visualization. REA techniques include endometrial laser ablation, transcervical resection of the endometrium, and rollerball endometrial ablation. Non-resectoscopic endometrial ablation (NREA) uses a variety of energy sources to non-selectively destroy the endometrial lining and include thermal balloon endometrial ablation, microwave endometrial ablation, hydrothermal ablation, bipolar radiofrequency endometrial ablation, endometrial cryotherapy, and more recently vapor endometrial ablation. NREA technologies require short surgical time and can also be performed in the outpatient setting. Vapor EA is one of the newest approaches in the field. In this context, the Aqua Therapeutics Thermal Therapy Vapor Ablation system (ATTTVAS; AQUA Therapeutics Inc.) is a novel system designed to ablate uterine tissue using vapor thermal therapy technology. The ATTTVAS is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. In this Pre-Market, Traditional Feasibility, Pilot, Interventional, Clinical Investigation we aim to evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women with Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
Detailed description
The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is a system designed to ablate uterine tissue by vapor thermal therapy technology. The ATTTVAS consists of a reusable Generator, a DISPOSABLE APPLICATOR, a DISPOSABLE CATHETER and a SYRINGE. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well. For each participant enrolled, a total of 7 visits (5 on-site and 2 remote) will be planned according to the flowchart. One unscheduled visit can be planned on-site according to Principal Investigator's judgement between V2 and V5/EOS visits. If the Investigator can complete all the assessments foreseen at baseline visit (V0) and V1-EA in one day, V0 and V1 may coincide.
Each participant, after signing the Informed Consent Form (ICF), will enter a screening phase (V-1) during which several assessments (e.g., demographics, medical history, current menstrual condition, blood analysis) will be conducted. At the screening visit, the participants will receive a menstrual calendar and a PBAC to be completed. The PBAC score must be recorded as soon as available to confirm that the subject can be enrolled at baseline (PBAC must be ≥150). The PBAC score will also be recorded at the EOS visit. At baseline (V0) and at EOS, on site, the participants will also complete the Menorrhagia Impact Questionnaire (MIQ). At V1, the enrolled participants will undergo EA with the ATTTVAS. EA must be performed within 15-20 days from the beginning of the menstrual cycle. EA cannot be performed in the presence of heavy menstrual bleeding, but it can be performed in the presence of light bleeding/spotting. Sedation will be performed before EA as per clinical practice. The duration (seconds) of the ablation cycle (the treatment typically runs for 90 seconds) will be recorded on the CRF. After the procedure is completed, the PI will fill in a questionnaire on procedural ease of use. Device deficiencies (if any) will be recorded. At discharge, after 24 hours and 1 week from discharge, the participants will be asked to rate pain intensity on a Numeric Rating Scale (NRS). At discharge, the participants will receive a diary, to record AEs and concomitant medications, a PBAC and a menstrual calendar to be completed during the study period. Satisfaction with the procedure will be evaluated using a 5-Likert Scale (completed by the PI and the participants) at discharge and EOS visits. Gynecological examination and vital signs monitoring will be performed at applicable visits (see flowchart). AEs, concomitant medications and current menstrual condition will be monitored during the entire study period. To evaluate the need for surgical or medical intervention to treat AUB after EA, any surgical or medical intervention required to treat AUB after EA will be recorded during the study.
A Data and Safety Monitoring Board (DSMB), appointed by the Sponsor, will review the adverse events reported in the study and make recommendations to the Sponsor regarding any actions (continue, suspend, modify, or stop the clinical investigation) to be taken. For safety reasons, the first DSMB meeting will be triggered after the occurrence of 5 SADEs related to the ATTTVAS (if any).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- this is a A Pre-Market, Traditional Feasibility, Pilot, Interventional, Clinical Investigation to Evaluate the Safety and the Performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) In Premenopausal Women with Abnormal Uterine Bleeding (AUB) and a History of Cesarean Section.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) medical device | Experimental | Device: Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)All Patients shall be screened for initial study eligibility by the Principal Investigator at the investigational site. Potential candidates, that according to the investigator judgment should be treated with IP, will be identified, with the assessment of their eligibility criteria, by the study site Principal Investigator and research staff. Patients will be considered to be enrolled in the study once they have met all of the inclusion and none of the exclusion criteria. Patients who do not meet the criteria will not be enrolled in the study. The patient involvement in the study will last until the EOS visit. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed participant informed consent form (ICF).
- Females aged ≥ 30 years and ≤ 55 years at baseline with no desire to conceive, with or without simple endometrial hyperplasia (without atypia) and with a history of cesarean section.
- Diagnosis of AUB.
- Documented premenopausal status (follicle-stimulating hormone (FSH) level ≤ 40 mIU/mL), women who don't want to receive hormonal treatment or who have failed to respond to hormonal treatment.
- Pictorial Blood Loss Assessment Chart (PBAC) score ≥150 at baseline.
Key exclusion criteria (24 listed)
- BMI ≥40
- Postmenopausal status.
- Undiagnosed vaginal bleeding.
- Cesarean scar defect which in the opinion of the Investigator is contraindicating endometrial ablation.
- A participant with a history of a prior completed endometrial ablation procedure and/or endometrial resection including endometrial ablation/resection performed immediately (between the screening visit and the EA procedure) prior to the ATTTVAS ablation treatment regardless of the modality by which it was performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)The Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) is indicated to ablate the endometrial lining of the uterus in premenopausal women with abnormal uterine bleeding (AUB) due to benign causes for whom childbearing is complete. The ATTTVAS is intended to be used by qualified healthcare professionals specifically trained in the field of endometrial ablation. The ATTTVAS is intended for outpatient use although it can easily be utilized in both a surgery centre and the operating room as well | Device | Treatment with Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) medical device |
Primary outcome
Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.
Time frame: V-1(within40 days before baseline);V0 (baseline); V1 (day 2, EndoAblation_discharge)V2(phone call after 24hours after discharge);V3(1week after V1)V4(6 weeks afterV1);unscheduled visit (betweenV2 andV5);V5(12weeksAfterDischarge)
The event, date of onset, severity, duration, and relationship to the device will be recorded. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken.
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital sign.
Time frame: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg)
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs.
Time frame: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
Safety will be monitored through Heart Rate measurement. Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm)
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through vital signs.
Time frame: V1 (day 2, Endometrial ablation) and unscheduled visit that could be taken between phone call after 24hours after discharge and 12weeksAfterDischarge
Safety will be monitored through measurement of the oxygen levels. 2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood. The measurement of O2 is performed using a non-invasive device known as a pulse oximeter.
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data
Time frame: V-1 (within 40 days before baseline); V5 (12 weeks after V1)
Blood analyses will include: Hemoglobin g/dL
To evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS). Safety will be monitored through laboratory data
Time frame: V-1 (within 40 days before baseline); V5 (12 weeks after V1)
Blood analyses will include: - Hematology: complete blood count (including red blood cell count, white blood cell count, platelet count)
9 secondary outcomes
To evaluate the performance of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) by assessing the change in menstrual blood loss during the study, as measured by the Pictorial Blood Loss Assessment Chart (PBAC) score.
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate the effect of menstrual blood loss on the quality of life
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate pain intensity after treatment
Time frame: V1 (day 2, at discharge); V2(phone call after 24hours after discharge);V3(1week after V1)
To evaluate procedure difficulty
Time frame: V1 (day 2, at Endometrial Ablation)
To evaluate menstrual changes (menstrual frequency).
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate menstrual changes (menstrual duration).
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate menstrual changes (menstrual regularity).
Time frame: V0 (baseline); V5(12 weeksAfterDischarge)
To evaluate patient's satisfaction with the ATTTVAS.
Time frame: V1 (day 2, at discharge) V5(12 weeksAfterDischarge)
To evaluate PI's satisfaction with the ATTTVAS.
Time frame: V1 (day 2, at Endometrial Ablation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in people with Menorrhagia, run by Aqua Therapeutics, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burghard Abendstein, MD (0043-5522-303-2201, Burghard.Abendstein@lkhf.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration. (time frame: V-1(within40 days before baseline);V0 (baseline); V1 (day 2, EndoAblation_discharge)V2(phone call after 24hours after discharge);V3(1week after V1)V4(6 weeks afterV1);unscheduled visit (betweenV2 andV5);V5(12weeksAfterDischarge)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.