Heavy Menstrual BleedingNCT06122363
Impact of Incomplete Endometrial Ablation
An observational study of Heavy Menstrual Bleeding, run by Maxima Medical Center at 1 site in Netherlands.
Trial summary
The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- hysteroscopy
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 30 Dec 2025
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective cohort study was carried out using the data of women who participated in the MIRA study and the MIRA2 study including RCT and prospective cohort database. These women have given informed consent for their data to be used for future research into treatments for heavy menstrual bleeding. To be eligible for study inclusion, women had to suffer from heavy menstrual bleeding, and have undergone Novasure endometrial ablation at Máxima MC between January 2012 and July 2023. Women were excluded from the database if the hysteroscopy images were not saved, or these images were of poor quality.
Who may be able to join
- Endometrial ablation between 2012 and 2023 in Máxima Medical Centre
- Women had to suffer from heavy menstrual bleeding
Who cannot join
- No saved hysteroscopy images or bad quality hysteroscopy images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Incomplete Endometrial Ablation on the Success Rate of Novasure Endometrial Ablation
The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.
Read the detailed description
The primary outcome is blood loss at 24 months after treatment, measured with the PBAC-score according to Higham. To calculate this score women were asked, in the MIRA and MIRA2 study, to record their menstrual blood loss for one month counting the number of super tampons or pads used each day. The total score was calculated using a score of 1 for each lightly saturated tampons. For pads the scores were respectively 1, 5 and 20. Secondary outcome measures were controlled bleeding, defined as a PBAC-score not exceeding 75 points, PBAC score of zero, re-intervention rate 24 months after treatment, satisfaction with treatment (measured with a 5-point Likert scale) and dysmenorrhea.
In addition, multiple variables were analyzed in predicting the occurrence of incomplete endometrial ablation, including age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization. Information was collected from EPD and the MIRA and MIRA2 databases.
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- hysteroscopy
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopyDevice
uterine hysteroscopy right after Novasure endometrial ablation
| Study group | Role | What they receive |
|---|---|---|
| Complete Novasure endometrial ablation | After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation Receives: Device: hysteroscopy | |
| Incomplete Novasure endometrial ablation | After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation Receives: Device: hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pictorial Blood Assessment Chart (PBAC) score
Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding.
Measured: 24 months
Secondary outcomes (4)
Rate of reintervention
Surgical and Medical reintervention
Measured: 24 months
Dysmennorrhea
Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe.
Measured: 24 months
Number of patients having controlled bleeding
Pictorial Blood Assessment Chart (PBAC) score less than 75.
Measured: 24 months
Satisfaction of the patient with the treatment
Satisfaction measured with a 5-point Likert scale. 1=very unsatisfied, 2= unsatisfied, 3= neutraal, 4= satisfied, 5= very satisfied.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danique Roelen, Maxima Medical Center
- Investigators
- Marlies M.Y. Bongers, PhD, MD, Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122363
- Sponsor's protocol ID
- Incomplete Novasure ablation
- Status last verified
- Jun 2025
- First submitted
- 5 Nov 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Incomplete Endometrial Ablation on the Success Rate of Novasure Endometrial Ablation
- ClinicalTrials.gov ID
- NCT06122363
- Acronym / sponsor ID
- Incomplete Novasure ablation
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Nov 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.
The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.
Detailed description
The primary outcome is blood loss at 24 months after treatment, measured with the PBAC-score according to Higham. To calculate this score women were asked, in the MIRA and MIRA2 study, to record their menstrual blood loss for one month counting the number of super tampons or pads used each day. The total score was calculated using a score of 1 for each lightly saturated tampons. For pads the scores were respectively 1, 5 and 20. Secondary outcome measures were controlled bleeding, defined as a PBAC-score not exceeding 75 points, PBAC score of zero, re-intervention rate 24 months after treatment, satisfaction with treatment (measured with a 5-point Likert scale) and dysmenorrhea.
In addition, multiple variables were analyzed in predicting the occurrence of incomplete endometrial ablation, including age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization. Information was collected from EPD and the MIRA and MIRA2 databases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Novasure endometrial ablation | – | Device: hysteroscopyAfter treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation |
| Incomplete Novasure endometrial ablation | – | Device: hysteroscopyAfter treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective cohort study was carried out using the data of women who participated in the MIRA study and the MIRA2 study including RCT and prospective cohort database. These women have given informed consent for their data to be used for future research into treatments for heavy menstrual bleeding. To be eligible for study inclusion, women had to suffer from heavy menstrual bleeding, and have undergone Novasure endometrial ablation at Máxima MC between January 2012 and July 2023. Women were excluded from the database if the hysteroscopy images were not saved, or these images were of poor quality.
Key inclusion criteria (2 listed)
- Endometrial ablation between 2012 and 2023 in Máxima Medical Centre
- Women had to suffer from heavy menstrual bleeding
Key exclusion criteria (1 listed)
- No saved hysteroscopy images or bad quality hysteroscopy images
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 |
|---|---|---|
| hysteroscopyuterine hysteroscopy right after Novasure endometrial ablation | Device | Complete Novasure endometrial ablation, Incomplete Novasure endometrial ablation |
Primary outcome
Pictorial Blood Assessment Chart (PBAC) score
Time frame: 24 months
Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding.
4 secondary outcomes
Rate of reintervention
Time frame: 24 months
Dysmennorrhea
Time frame: 24 months
Number of patients having controlled bleeding
Time frame: 24 months
Satisfaction of the patient with the treatment
Time frame: 24 months
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 12 Jun 2025.
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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. This study is not recruiting at the moment.
Marlies M.Y. Bongers, PhD, MD principal investigator
Maxima Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding, run by Maxima Medical Center at 1 site in Netherlands.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 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 Netherlands. 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?
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?
Pictorial Blood Assessment Chart (PBAC) score (time frame: 24 months). 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 12 Jun 2025.