Abnormal Uterine BleedingAUBNCT04381416
Study to Assess the Safety and Efficacy of the IUB SEAD™ Device
A study testing SEAD treatment in people with Abnormal Uterine Bleeding, run by Ocon Medical Ltd. at 1 site in Bulgaria.
Trial summary
Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in women suffering from abnormal uterine bleeding. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- SEAD treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Sep 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subject age 35 to 50 years, inclusive
- Suffering from heavy menstrual bleeding with no definable organic cause and are candidates for global endometrial ablation or surgical treatment
- Have a histological finding in a recent (max 4-month-old, with a window of 1 month) endometrial biopsy (Pipelle® or other non-treatment-based biopsy) that demonstrates benign endometrial histology: proliferative endometrium and/or disordered endometrium and/or histological findings associated with dysfunctional endometrium (e.g. irregular shading, un-ovulatory bleeding and such); no histological findings of hyperplasia are allowed
- Premenopausal status confirmed by FSH level measurement at screening (FSH < 40 IU/L). FSH level measurement will be repeated in case of a borderline result
- Screening hemoglobin levels >9.0 g/dL
- Uterine sound measurement of 6.5-11 cm (external os to internal fundus)
Show all 16Show fewer
- PBAC score of >150 for 3 months prior to study treatment or PBAC score >150 one month prior to study treatment for women who had at least 3 prior months (documented) of failed medical therapy
- Predictable, cyclic menstrual cycles
- Negative serum pregnancy test at the Screening visit and on the day of SEAD™ treatment
- Sexually active women must agree to use an effective method of contraception throughout the course of the study. For this study, effective methods of contraception are considered to be those listed below:
- Barrier method, i.e., (a) condom (male or female) with spermicide or (b) diaphragm with spermicide or
- Vasectomy (partner), or
- Abstinence, if in line with the preferred and usual lifestyle of the subject [where abstinence is defined as refraining from heterosexual intercourse]
- Subject able to understand and sign a written informed consent form
- Subject willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram
Who cannot join
- Pregnant women or those who desire to conceive at any time in the future
- Congenital malformation of the uterine cavity (bicornuate, septate)
- Inability to visualize the uterine cavity because of intracavitary pathology and/or significant uterine asymmetry, including patients with submucous myomas and/or polyps and synechiae that heavily distort the uterine cavity
- Underwent prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy, classical Cesarean section, endometrial ablation, hysteroscopic resection) or a uterine biopsy accompanied by curettage in the last 12 months
- Have abnormal endometrial biopsy (i.e., unresolved adenomatous complex hyperplasia, endometrial cancer)
- Have a documented clinical history of metal allergy or hypersensitivity
Show all 19Show fewer
- Suffers from active endometritis, active pelvic inflammatory disease (PID) or active sexually transmitted disease (STD)
- Suffers from active infection of the genitals, vagina, cervix, or uterus
- Presence of bacteremia, sepsis, or other active systemic infection
- Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
- Known clotting defects or bleeding disorders or subjects who went through blood transfusion (for any reason) in the three months prior enrollment
- Currently using anticoagulant treatment
- Subjects with abnormal Papanicolaou (Pap) test or atypical squamous cells of undetermined significance (ASCUS) with positive high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe, and prior to SEAD™ treatment. Alternatively, a colposcopy performed prior to SEAD™ treatment, that showed evidence of dysplasia requiring treatment. In case treatment was performed > 6 months prior to enrollment and follow-up was done with no evidence of disease by clinical evaluation, the subject is eligible.
- Previously had endometrial ablation procedure of any kind
- Suffers from clinically significant adenomyosis indicated by subject complaints, imaging or clinician's judgment
- Presence of an implantable contraceptive device
- Post-partum ≤ 6-months
- Currently participating in or considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
- Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could present an increased risk for the subject or impact the subject's ability to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-pivotal, Randomized Study to Assess the Safety and Efficacy of the IUB SEAD™ Device in Women Suffering From Abnormal Uterine Bleeding
Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in women suffering from abnormal uterine bleeding.
Read the detailed description
Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday activities, can lead to iron deficiency and in severe cases, can necessitate emergency medical care.
While pharmacologic treatment options exist, some women desire a treatment that requires less maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied to manage AUB and can be performed using resectoscopic instruments or with a non-resectoscopic approach, in which the device is inserted into the uterine cavity and delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial ablation has become an accepted office-based procedure, but requires training in administration and response to complications of conscious sedation and of assisting personnel.
The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is expected to be simpler than the currently available ablation methods and to result in a clinically meaningful delay or abolishment of the need for hysterectomy
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- SEAD treatment
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEAD treatmentDevice
up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| Cohort I: SEAD treatment | Experimental | Following the first SEAD™ treatment, women who experience a sub-optimal treatment response (at least 3 months after the first treatment) will be eligible to receive a second SEAD™ treatment (see re-treatment criteria below), which will be performed during the first 1-3 days following the cessation of their menses immediately following decision to retreat. Receives: Device: SEAD treatment |
| Cohort II: Repeted SEAD treatment 1m post op | Experimental | Following the first SEAD™ treatment, women will undergo a second SEAD™ treatment during the first 1-3 days following the cessation of their next menses. Receives: Device: SEAD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
assess the 12-month safety of IUB SEAD treatment in women suffering from AUB.
Measured: 12 months
Pictorial Blood Loss Assessment Chart changes from baseline
To assess the efficacy of IUB SEAD treatment in women suffering from AUB, 12 months after treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Sep 2019
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocon Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rouemen Velev, Md, Principal investigator, Sheynovo medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381416
- Sponsor's protocol ID
- 55P112
- Acronym
- AUB
- Status last verified
- Nov 2023
- First submitted
- 4 May 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-pivotal, Randomized Study to Assess the Safety and Efficacy of the IUB SEAD™ Device in Women Suffering From Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT04381416
- Acronym / sponsor ID
- AUB / 55P112
- Conditions
- Abnormal Uterine Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ocon Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 May 2020 (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.
Pre-pivotal, randomized study to assess the safety and efficacy of the IUB SEAD™ device in women suffering from abnormal uterine bleeding.
Detailed description
Chronic abnormal uterine bleeding (AUB), involving menstrual bleeding of abnormal quantity, duration, or schedule, is experienced by 10-35% of women, and can markedly impact everyday activities, can lead to iron deficiency and in severe cases, can necessitate emergency medical care.
While pharmacologic treatment options exist, some women desire a treatment that requires less maintenance or is definitive. Endometrial ablation is a minimally invasive approach applied to manage AUB and can be performed using resectoscopic instruments or with a non-resectoscopic approach, in which the device is inserted into the uterine cavity and delivers energy to uniformly destroy the uterine lining. Non-resectoscopic endometrial ablation has become an accepted office-based procedure, but requires training in administration and response to complications of conscious sedation and of assisting personnel.
The IUB SEAD™ device is a novel Spherical Endometrial Ablation Device, developed to allow for a simple, office-based chemical endometrial ablation to treat AUB. The suggested procedure is expected to be simpler than the currently available ablation methods and to result in a clinically meaningful delay or abolishment of the need for hysterectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I: SEAD treatment | Experimental | Device: SEAD treatmentFollowing the first SEAD™ treatment, women who experience a sub-optimal treatment response (at least 3 months after the first treatment) will be eligible to receive a second SEAD™ treatment (see re-treatment criteria below), which will be performed during the first 1-3 days following the cessation of their menses immediately following decision to retreat. |
| Cohort II: Repeted SEAD treatment 1m post op | Experimental | Device: SEAD treatmentFollowing the first SEAD™ treatment, women will undergo a second SEAD™ treatment during the first 1-3 days following the cessation of their next menses. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Female subject age 35 to 50 years, inclusive
- Suffering from heavy menstrual bleeding with no definable organic cause and are candidates for global endometrial ablation or surgical treatment
- Have a histological finding in a recent (max 4-month-old, with a window of 1 month) endometrial biopsy (Pipelle® or other non-treatment-based biopsy) that demonstrates benign endometrial histology: proliferative endometrium and/or disordered endometrium and/or histological findings associated with dysfunctional endometrium (e.g. irregular shading, un-ovulatory bleeding and such); no histological findings of hyperplasia are allowed
- Premenopausal status confirmed by FSH level measurement at screening (FSH < 40 IU/L). FSH level measurement will be repeated in case of a borderline result
- Screening hemoglobin levels >9.0 g/dL
Key exclusion criteria (19 listed)
- Pregnant women or those who desire to conceive at any time in the future
- Congenital malformation of the uterine cavity (bicornuate, septate)
- Inability to visualize the uterine cavity because of intracavitary pathology and/or significant uterine asymmetry, including patients with submucous myomas and/or polyps and synechiae that heavily distort the uterine cavity
- Underwent prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy, classical Cesarean section, endometrial ablation, hysteroscopic resection) or a uterine biopsy accompanied by curettage in the last 12 months
- Have abnormal endometrial biopsy (i.e., unresolved adenomatous complex hyperplasia, endometrial cancer)
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 |
|---|---|---|
| SEAD treatmentup to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic | Device | Cohort I: SEAD treatment, Cohort II: Repeted SEAD treatment 1m post op |
Primary outcome
Adverse events
Time frame: 12 months
assess the 12-month safety of IUB SEAD treatment in women suffering from AUB.
Pictorial Blood Loss Assessment Chart changes from baseline
Time frame: 12 months
To assess the efficacy of IUB SEAD treatment in women suffering from AUB, 12 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Abnormal Uterine Bleeding
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
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. This study is not recruiting at the moment.
Rouemen Velev, Md principal investigator
Sheynovo medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEAD treatment in people with Abnormal Uterine Bleeding, run by Ocon Medical Ltd. at 1 site in Bulgaria.
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 16 inclusion and 19 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: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 12 months). The study lists 2 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 8 Nov 2023.