Menstrual Bleeding, HeavyRAMBOSNCT05856838
NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding
A study testing NovaSure ablation in people with Menstrual Bleeding, Heavy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of… Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Menstrual Bleeding, Heavy
- What is being tested?
- NovaSure ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Nov 2023to 31 Dec 2026
- 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 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≥ 35 years - ≤ 50 years
- Heavy menstrual bleeding (PBAC ≥ 150)
- Unsuccessful drug treatment, contraindication to drug treatment or rejection of drug treatment by the patient
- The absence of intra-uterine abnormalities on diagnostic hysteroscopy
- Endometrial biopsy (pipelle) is normal
- Finished childbearing
Who cannot join
- Pregnancy
- Endometritis
- Adenomyosis
- Contra-indication for local anaesthetics
- Presence of severe systemic disease (≥ASA 3)
- Previously performed endometrial ablation
Show all 12Show fewer
- Poor understanding of Dutch language
- History of pelvic malignancy
- Presence of an intra uterine device (IUD)
- Cavity pathology (myoma, septum)
- Cavity length < 4 cm
- Each uterine incision other than conventional caesarean incision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, East Flanders, 9000
Study Coordinator, 0032 9 332 07 58, gynobs.studies@uzgent.be
About this study
Official title: Radiofrequency Ablation in Women With Heavy Menstrual Bleeding, Procedure in an Outpatient Setting
Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life.
In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified.
Read more
The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications.
An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia.
The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours)
This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout).
The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.
Read the detailed description
Eligible women will be identified by a clinician of the gynaecological department. A diagnostic hysteroscopy to rule out intrauterine abnormalities, followed by a pipelle will be done according to the local protocol of each participating centre. Written informed consent will be obtained. Participants will be asked to quantify their menstrual blood loss using the Pictorial Blood loss Assessment Chart (PBAC score) (appendix 1) before the procedure and complete the SF-36 questionnaire (appendix 2). The Novasure procedure will be scheduled at the outpatient clinic. Women will be advised to use paracetamol 1000mg and Naproxen 500mg 1 hour before the procedure. If oral NSAIDs are contra-indicated, premedication will be limited to paracetamol. During the procedure a dedicated nurse will offer personal support. Baseline characteristics (age, BMI, parity, dysmenorrhea, day of menstrual cycle at time of ablation, duration of the menstruation, use of analgesics prior to treatment and position of the uterus) will be collected. Vital parameters will be monitored during the procedure. After disinfection and speculum placement, paracervical anaesthesia (1ml of ropivacaine (Naropin) 2mg/ml) will be injected in the anterior lip of the cervix, subsequently a tenaculum will be placed. This will be followed by further paracervical infiltrations (10ml injections of ropivacaine at 3 and 9 o'clock paracervical and in both uterosacral ligaments (at 5 and 7 o'clock retrocervical)). Thereafter, a fundal infiltration will be performed through a diagnostic hysteroscopy using the Williams Cystoscopic Injection needle (Cook® Medical). Ropivacaine will be injected at 4 points in the myometrium of the fundus: 1 ml on either side of the midline and 1 ml medial to both tubal ostia. After the infiltration, speculum and tenaculum will be removed, and a 10-minute break will be taken before continuing the procedure.
After speculum placement, hysterometry will be performed and the cervix will be dilated to Hegar 8mm followed by the insertion of the NovaSure device (Classic, 8mm). A cavity assessment will be done and, if passed, ablation will start (60-90 sec). The settings of the device will be collected. After the procedure is done women can recover until they feel fit to leave (foreseen 2 to 4 hours postoperative, the time of discharge will be noted). The participants will be advised to use paracetamol 1000mg every 6 hours and Naproxen 500mg every 12 hours during 1-2 days. If oral NSAIDs were contra-indicated Tramadol will be advised. VAS scales will be used to report the intensity of the pain during the procedure and two hours after the procedure. Follow-up examination will be done 6 weeks and 3 months after the procedure. Adverse events will be recorded during the procedure and at the 6 weeks and 3 months follow-up. At the 3 months follow-up visit the following variables will be collected: patient satisfaction, symptom relief, amenorrhea rate, quality of life (SF-36), PBAC score, adverse events, additional treatment and whether they would recommend the procedure to a friend.
- Conditions
- Menstrual Bleeding, Heavy
- Being tested
- NovaSure ablation
- Keywords
- Menorrhagia/surgery, Endometrial Ablation Techniques, Endometrium/surgery
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaSure ablationDevice
Ablation of the endometrial tissue using the NovaSure device
| Study group | Role | What they receive |
|---|---|---|
| NovaSure ablation | Experimental | Not described Receives: Device: NovaSure ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction assessed bij a 5-point Likert Scale
Patient satisfaction of the procedure on a 5-point Likert Scale
Measured: 3 months after the procedure
Secondary outcomes (8)
Pain assessed by VAS
Pain scores during and after the procedure by visual analogue score (VAS) VAS: 0-10 (0 = no pain, 1-3 = mild pain, 4-6 moderate pain, 7-9 very severe pain, 10 worst pain possible) A higher score means a worse outcome
Measured: During the procedure and 2 hours after the procedure
Symptom relief assessed bij a 5-point Likert Scale
Symptom relief on a 5-point Likert Scale
- Very unsatisfied
- A little bit unsatisfied
- Neutral
- Satisfied
- Very satisfied
A high score means a good outcome.
Measured: 3 months after the procedure.
Amenorrhea rate
Frequency of the menstruation cycle
Measured: at 6 weeks and 3 months after the procedure.
Menstrual blood loss
quantified by the Pictorial Blood loss Assessment Chart (PBAC score) A high score means more bloodloss (maximum 150 score).
Measured: 1 month before and 3 months after the procedure.
Health related quality of life assessment
Health related quality of life measured by the SF-36 questionnaire
Measured: 1 month before and 3 months after the procedure.
Adverse events
Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational medical device.
A serious adverse event is any untoward medical occurrence or effect that
- results in death;
- is life threatening (at the time of the event);
- requires hospitalization or prolongation of existing inpatients' hospitalization;
- results in persistent or significant disability or incapacity;
- any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator. An elective hospital admission will not be considered as a serious adverse event.
Measured: During and up to 6 weeks and 3 months after the procedure.
Any additional treatment needed after NovaSure procedure
Non-hormonal medication, hormonal medication (oral combination pil, IUD), surgery (hysterectomy for example).
Measured: 3 months after the procedure.
Recommendation to a friend
Whether they would recommend the procedure to a friend (Yes/No) at 3 months after the procedure.
Measured: 3 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start24 Nov 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Bleeding, HeavyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856838
- Sponsor's protocol ID
- ONZ-2023-0131
- Acronym
- RAMBOS
- Status last verified
- Jan 2025
- First submitted
- 3 May 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation in Women With Heavy Menstrual Bleeding, Procedure in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT05856838
- Acronym / sponsor ID
- RAMBOS / ONZ-2023-0131
- Conditions
- Menstrual Bleeding, Heavy
- Keywords
- Menorrhagia/surgery, Endometrial Ablation Techniques, Endometrium/surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 May 2023 (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.
Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life.
In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified.
The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications.
An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia.
The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours)
This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout).
The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.
Detailed description
Eligible women will be identified by a clinician of the gynaecological department. A diagnostic hysteroscopy to rule out intrauterine abnormalities, followed by a pipelle will be done according to the local protocol of each participating centre. Written informed consent will be obtained. Participants will be asked to quantify their menstrual blood loss using the Pictorial Blood loss Assessment Chart (PBAC score) (appendix 1) before the procedure and complete the SF-36 questionnaire (appendix 2). The Novasure procedure will be scheduled at the outpatient clinic. Women will be advised to use paracetamol 1000mg and Naproxen 500mg 1 hour before the procedure. If oral NSAIDs are contra-indicated, premedication will be limited to paracetamol. During the procedure a dedicated nurse will offer personal support. Baseline characteristics (age, BMI, parity, dysmenorrhea, day of menstrual cycle at time of ablation, duration of the menstruation, use of analgesics prior to treatment and position of the uterus) will be collected. Vital parameters will be monitored during the procedure. After disinfection and speculum placement, paracervical anaesthesia (1ml of ropivacaine (Naropin) 2mg/ml) will be injected in the anterior lip of the cervix, subsequently a tenaculum will be placed. This will be followed by further paracervical infiltrations (10ml injections of ropivacaine at 3 and 9 o'clock paracervical and in both uterosacral ligaments (at 5 and 7 o'clock retrocervical)). Thereafter, a fundal infiltration will be performed through a diagnostic hysteroscopy using the Williams Cystoscopic Injection needle (Cook® Medical). Ropivacaine will be injected at 4 points in the myometrium of the fundus: 1 ml on either side of the midline and 1 ml medial to both tubal ostia. After the infiltration, speculum and tenaculum will be removed, and a 10-minute break will be taken before continuing the procedure.
After speculum placement, hysterometry will be performed and the cervix will be dilated to Hegar 8mm followed by the insertion of the NovaSure device (Classic, 8mm). A cavity assessment will be done and, if passed, ablation will start (60-90 sec). The settings of the device will be collected. After the procedure is done women can recover until they feel fit to leave (foreseen 2 to 4 hours postoperative, the time of discharge will be noted). The participants will be advised to use paracetamol 1000mg every 6 hours and Naproxen 500mg every 12 hours during 1-2 days. If oral NSAIDs were contra-indicated Tramadol will be advised. VAS scales will be used to report the intensity of the pain during the procedure and two hours after the procedure. Follow-up examination will be done 6 weeks and 3 months after the procedure. Adverse events will be recorded during the procedure and at the 6 weeks and 3 months follow-up. At the 3 months follow-up visit the following variables will be collected: patient satisfaction, symptom relief, amenorrhea rate, quality of life (SF-36), PBAC score, adverse events, additional treatment and whether they would recommend the procedure to a friend.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovaSure ablation | Experimental | Device: NovaSure ablation |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ≥ 35 years - ≤ 50 years
- Heavy menstrual bleeding (PBAC ≥ 150)
- Unsuccessful drug treatment, contraindication to drug treatment or rejection of drug treatment by the patient
- The absence of intra-uterine abnormalities on diagnostic hysteroscopy
- Endometrial biopsy (pipelle) is normal
Key exclusion criteria (12 listed)
- Pregnancy
- Endometritis
- Adenomyosis
- Contra-indication for local anaesthetics
- Presence of severe systemic disease (≥ASA 3)
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 |
|---|---|---|
| NovaSure ablationAblation of the endometrial tissue using the NovaSure device | Device | NovaSure ablation |
Primary outcome
Patient satisfaction assessed bij a 5-point Likert Scale
Time frame: 3 months after the procedure
Patient satisfaction of the procedure on a 5-point Likert Scale
8 secondary outcomes
Pain assessed by VAS
Time frame: During the procedure and 2 hours after the procedure
Symptom relief assessed bij a 5-point Likert Scale
Time frame: 3 months after the procedure.
Amenorrhea rate
Time frame: at 6 weeks and 3 months after the procedure.
Menstrual blood loss
Time frame: 1 month before and 3 months after the procedure.
Health related quality of life assessment
Time frame: 1 month before and 3 months after the procedure.
Adverse events
Time frame: During and up to 6 weeks and 3 months after the procedure.
Any additional treatment needed after NovaSure procedure
Time frame: 3 months after the procedure.
Recommendation to a friend
Time frame: 3 months after the procedure.
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 26 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovaSure ablation in people with Menstrual Bleeding, Heavy, run by University Hospital, Ghent at 1 site in Belgium.
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 6 inclusion and 12 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 26 Dec 2025. 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 Belgium. 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 Studies Vrouwenkliniek (+32 9 332 37 83, studieco.vrouwenkliniek@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction assessed bij a 5-point Likert Scale (time frame: 3 months after the procedure). 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 26 Dec 2025.