Uterine PolypsHYPHOPNCT07908615
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
A study testing Operating-room hysteroscopy with resectoscope and Outpatient hysteroscopic morcellation/aspiration in people with Uterine Polyps and Uterine Fibroids, run by Nantes University Hospital at 9 sites in France.
Trial summary
HYPHOP is a multicenter, randomized clinical trial comparing two care pathways for women who need operative hysteroscopy to treat intrauterine lesions, such as uterine polyps, small submucosal fibroids, or retained pregnancy tissue. Participants will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uterine Polyps, Uterine Fibroids, Retained Products of Conception
- What is being tested?
- Operating-room hysteroscopy with resectoscope and Outpatient hysteroscopic morcellation/aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 9 sitesFrance
- Study dates
- Nov 2026to Mar 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older.
- One or more intrauterine submucosal fibroids, FIGO types 0, 1 or 2, measuring 2 cm or less, confirmed by diagnostic hysteroscopy; OR one or more intrauterine polyps confirmed by diagnostic hysteroscopy; OR retained pregnancy tissue confirmed by diagnostic hysteroscopy.
- Willingness to participate and provision of written informed consent.
- Willingness to complete follow-up for at least 12 months after the intervention and, when the intervention is delayed after inclusion, for up to 16 months from inclusion.
- Affiliation with or entitlement to a health insurance scheme.
Who cannot join
- Does not wish to undergo surgical treatment.
- Anticoagulant treatment that prevents outpatient operative hysteroscopy.
- Pregnancy or breastfeeding.
- Active pelvic or genital infection.
- Adult under a legal protection measure.
- Inability to complete the study questionnaires.
- Placement under judicial safeguard
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites
Hopital ESTAING
Clermont-Ferrand, 63100
Dr Anne-Sophie GREMEAU, NK, asgremeau@chu-clermontferrand.fr
Anne-Sophie GREMEAU, Dr
Hôpital intercommunal de Créteil
Créteil, 94010
Yann SALHI, Dr, NK, yann.salhi@chicreteil.fr
Yann SALHI, Dr
GHEM Simone VEIL Site Eaubonne
Eaubonne, 95602
Elie MIKHAEL, Dr, NK, elie.mikhael@ch-simoneveil.fr
Elie MIKHAEL, Dr
Ch Marmande Chic
Marmande, 47200
Nicolas NOCART, Dr, NK, nicolas.nocart@chicmt.fr
Nicolas NOCART, Dr
APHM Hopital Nord
Marseille, 13015
Antoine NETTER, Dr, NK, antoine.netter@ap-hm.fr
Antoine NETTER, Dr
CHU Saint Louis site Lariboisière - APHP-
Paris, 75010
Jeremy SROUSSI, Dr, NK, jeremy.sroussi@gmail.com
Jeremy SROUSSI, Dr
Chu Pitie Salpetriere
Paris, 75013
Geoffroy CANLORBE, Dr, geoffroy.canlorbe@aphp.fr
Geoffroy CANLORBE
CHU Robert Debré APHP
Paris, 75019
Svetlana LEVINTA, Dr, NK, svetlana.levinta@aphp.fr
Svetlana LEVINTA, Dr
CHI Poissy
Poissy, 78300
Rosa Montero-Macias, Dr, +33139274577, rosa.montero@ght-yvelinesnord.fr
Rosa MONTERO-MACIAS, Dr
About this study
Official title: Cost-utility Analysis of Office Hysteroscopic Morcellation/Aspiration Versus Conventional Operating-room Resectoscopy for Intrauterine Pathologies
HYPHOP is a multicenter, randomized clinical trial comparing two care pathways for women who need operative hysteroscopy to treat intrauterine lesions, such as uterine polyps, small submucosal fibroids, or retained pregnancy tissue.
Participants will be randomly assigned to one of two groups. The first group will undergo hysteroscopic morcellation/aspiration in an outpatient consultation room, without requiring an operating room. The second group will undergo hysteroscopy using a resectoscope in the operating room, usually under general or regional anesthesia.
Read more
The main objective is to determine whether outpatient hysteroscopic morcellation/aspiration provides better value for money than conventional operating-room hysteroscopy, by comparing costs and health-related quality of life over six months from inclusion.
The study will also compare symptoms, quality of life, pain, complications, the need for further treatment, patient and practitioner satisfaction, and healthcare resource use. The hypothesis is that the outpatient care pathway may reduce costs without compromising patient outcomes.
Read the detailed description
HYPHOP is a prospective, multicenter, open-label, randomized controlled trial with two parallel groups. The study evaluates two care pathways for women requiring operative hysteroscopy for intrauterine pathologies.
After diagnostic hysteroscopy confirms the indication for operative treatment, eligible participants who provide written informed consent will complete baseline questionnaires and be randomly assigned to one of two groups. Randomization will be stratified by study center and indication (fibroid, polyp, or retained pregnancy tissue).
In the first group, operative hysteroscopy will be performed using a morcellation/aspiration system in a dedicated outpatient consultation room. Analgesia options may include non-steroidal anti-inflammatory medication, local anesthesia, virtual reality, and/or an equimolar mixture of oxygen and nitrous oxide, according to the participant's preference and clinical circumstances.
In the second group, operative hysteroscopy will be performed using a resectoscope in the operating room, with general or regional anesthesia according to the usual care pathway and the clinical decision.
The intervention may take place on the day of inclusion or subsequently, depending on the assigned care pathway and operating-room or outpatient scheduling, with a maximum delay of four months after inclusion.
The primary objective is to conduct a cost-utility analysis comparing the two care pathways over a six-month horizon from inclusion, using a collective perspective. Health-related quality of life will be measured using the EQ-5D-5L questionnaire at inclusion, three months, and six months. Quality-adjusted life years (QALYs) will be estimated from these measurements, and costs will be compared between groups. The incremental cost-utility ratio will be expressed as cost per QALY, with results also presented as incremental net monetary benefit for different willingness-to-pay values.
The six-month horizon begins at inclusion rather than at the intervention because the time to treatment may differ between the two groups. Consequently, assessments at three and six months from inclusion may occur at different intervals after the intervention in the two groups.
Secondary assessments include treatment completeness, procedure duration, intraoperative complications, pain, analgesic use, symptoms measured using the Higham score and UFS-QoL questionnaire, health-related quality of life, the need for further treatment, healthcare resource use, length of hospital stay, and patient and practitioner satisfaction. A five-year budget impact analysis will also assess scenarios for the national adoption of outpatient hysteroscopic morcellation/aspiration.
The planned sample size is 474 participants.
- Being tested
- Operating-room hysteroscopy with resectoscope, Outpatient hysteroscopic morcellation/aspiration
- Keywords
- Hysteroscopy, Hysteroscopic morcellation, Hysteroscopic resectoscopy, Cost-utility analysis, Health-related quality of life, Intrauterine pathology
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating-room hysteroscopy with resectoscopeProcedure or surgery
A resectoscope is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the examination of the uterus and the treatment of gynecological conditions through the natural passages (vagina, cervix). It provides direct access to the interior of the uterine cavity without the need for an abdominal incision. The procedure is performed in the operating room under general or regional anesthesia.
The resectoscope is used for myomectomy, polypectomy, resection of retained trophoblasts or placental remnants, or division of a septum
The procedure is performed as follows:
- Positioning of the patient and anesthesia
- Insertion of the resectoscope and exploration
- Surgical phase
- Removal of the resectoscope and monitoring The procedure is contraindicated in cases of active genital infection
Outpatient hysteroscopic morcellation/aspirationProcedure or surgery
The therapeutic hysteroscope with fragmentation and aspiration is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the rapid and precise removal of abnormal tissue without the need for incisions. The procedure is performed in a dedicated examination room (clean room).
It can be used outside the operating room with or without local anesthesia.
Morcellation/aspiration hysteroscopy is indicated for myomectomy, polypectomy, and resection of retained trophoblasts or placental remnants. The procedure is performed as follows:
- Positioning of the patient, with or without multimodal anesthesia
- Insertion of the therapeutic fragmentation-aspiration hysteroscope and exploration
- Surgical phase
- Removal of the therapeutic fragmentation-aspiration hysteroscope and monitoring The procedure is contraindicated in cases of active genital infection
| Study group | Role | What they receive |
|---|---|---|
| Operating-room hysteroscopy with resectoscope | Active comparator | Participants undergo operative hysteroscopy using a resectoscope in the operating room, with general or regional anesthesia according to the usual care pathway and clinical decision. Receives: Procedure: Operating-room hysteroscopy with resectoscope |
| Outpatient hysteroscopic morcellation/aspiration | Experimental | Participants undergo operative hysteroscopy using a morcellation/aspiration system in a dedicated outpatient consultation room, without an operating-room pathway. Analgesia options may include non-steroidal anti-inflammatory medication, local anesthesia, virtual reality and/or an equimolar mixture of oxygen and nitrous oxide, according to participant preference and clinical circumstances. Receives: Procedure: Outpatient hysteroscopic morcellation/aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost-utility ratio of outpatient hysteroscopic morcellation/aspiration versus operating-room resectoscopy
Cost-utility analysis comparing the two care pathways from a collective perspective. Costs and quality-adjusted life years (QALYs) derived from EQ-5D-5L measurements will be compared between groups. The incremental cost-utility ratio will be expressed as cost per QALY and results will also be presented as incremental net monetary benefit at different willingness-to-pay thresholds.
Measured: Six months after inclusion
Secondary outcomes (12)
Five-year budget impact of national adoption of outpatient hysteroscopic morcellation/aspiration
Estimated financial impact for the French National Health Insurance system under scenarios of national adoption of outpatient hysteroscopic morcellation/aspiration instead of operating-room resectoscopy.
Measured: Five-year time horizon
Completeness of the operative hysteroscopy procedure
Presence of a residual lesion identified by the surgeon at the end of the procedure.
Measured: At the end of the procedure
Duration of the operative hysteroscopy procedure
Time in minutes from insertion of the hysteroscope into the cervical canal to completion of the operative procedure, marked by the final removal of the hysteroscope.
Measured: During the procedure
Intraoperative complications
Occurrence of complications including uterine perforation, procedure interruption for any reason, conversion to another technique, or other procedure-related complications specified in the protocol.
Measured: During the operative procedure
Pain intensity and analgesic use
Pain assessed using a numerical rating scale and additional analgesic use. For the resectoscope group, immediate postoperative pain is assessed 30 minutes after awakening, with a ±30-minute window.
Measured: During and at the end of the procedure, immediately after surgery, and at Day 7 after the intervention
Change in symptoms and disease-specific quality of life
Symptoms assessed using the Higham score and disease-specific quality of life assessed using the UFS-QoL questionnaire, at the time points specified in the protocol.
Measured: At inclusion; Day 7, Month 1 and Month 12 after intervention; and Months 3 and 6 after inclusion
Health-related quality of life measured using EQ-5D-5L
Health-related quality of life measured using the EQ-5D-5L questionnaire to estimate QALYs for the cost-utility analysis.
Measured: At inclusion and at Months 3 and 6 after inclusion
Need for further treatment or repeat intervention
Proportion of participants requiring further treatment or repeat intervention at the time points specified in the protocol.
Measured: At Months 1 and 12 after intervention, and Months 3 and 6 after inclusion
Time to treatment, hospital length of stay and healthcare resource use
Time from inclusion to intervention, hospital length of stay, healthcare consumption and analgesic use after the procedure.
Measured: From inclusion through the follow-up period, as applicable
Patient satisfaction with the procedure and care pathway
Satisfaction assessed on a 0-10 scale, including satisfaction with time to treatment, anesthesia, care pathway, procedure and pain management, and willingness to recommend the care pathway.
Measured: On the day of the procedure and at Day 7 after intervention
Practitioner satisfaction with the procedure and care pathway
Practitioner satisfaction assessed on a 0-10 scale, including satisfaction with time to treatment, anesthesia, care pathway, procedure and pain management.
Measured: On the day of the procedure
Acceptability of study participation
Number of women meeting eligibility criteria who decline participation and reasons for refusal
Measured: During recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine PolypsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault THUBERT, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908615
- Sponsor's protocol ID
- RC25_0526
- Other IDs
- 2026-A01251-50
- Acronym
- HYPHOP
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis of Office Hysteroscopic Morcellation/Aspiration Versus Conventional Operating-room Resectoscopy for Intrauterine Pathologies
- ClinicalTrials.gov ID
- NCT07908615
- Acronym / sponsor ID
- HYPHOP / RC25_0526
- Keywords
- Hysteroscopy, Hysteroscopic morcellation, Hysteroscopic resectoscopy, Cost-utility analysis, Health-related quality of life, Intrauterine pathology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 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.
HYPHOP is a multicenter, randomized clinical trial comparing two care pathways for women who need operative hysteroscopy to treat intrauterine lesions, such as uterine polyps, small submucosal fibroids, or retained pregnancy tissue.
Participants will be randomly assigned to one of two groups. The first group will undergo hysteroscopic morcellation/aspiration in an outpatient consultation room, without requiring an operating room. The second group will undergo hysteroscopy using a resectoscope in the operating room, usually under general or regional anesthesia.
The main objective is to determine whether outpatient hysteroscopic morcellation/aspiration provides better value for money than conventional operating-room hysteroscopy, by comparing costs and health-related quality of life over six months from inclusion.
The study will also compare symptoms, quality of life, pain, complications, the need for further treatment, patient and practitioner satisfaction, and healthcare resource use. The hypothesis is that the outpatient care pathway may reduce costs without compromising patient outcomes.
Detailed description
HYPHOP is a prospective, multicenter, open-label, randomized controlled trial with two parallel groups. The study evaluates two care pathways for women requiring operative hysteroscopy for intrauterine pathologies.
After diagnostic hysteroscopy confirms the indication for operative treatment, eligible participants who provide written informed consent will complete baseline questionnaires and be randomly assigned to one of two groups. Randomization will be stratified by study center and indication (fibroid, polyp, or retained pregnancy tissue).
In the first group, operative hysteroscopy will be performed using a morcellation/aspiration system in a dedicated outpatient consultation room. Analgesia options may include non-steroidal anti-inflammatory medication, local anesthesia, virtual reality, and/or an equimolar mixture of oxygen and nitrous oxide, according to the participant's preference and clinical circumstances.
In the second group, operative hysteroscopy will be performed using a resectoscope in the operating room, with general or regional anesthesia according to the usual care pathway and the clinical decision.
The intervention may take place on the day of inclusion or subsequently, depending on the assigned care pathway and operating-room or outpatient scheduling, with a maximum delay of four months after inclusion.
The primary objective is to conduct a cost-utility analysis comparing the two care pathways over a six-month horizon from inclusion, using a collective perspective. Health-related quality of life will be measured using the EQ-5D-5L questionnaire at inclusion, three months, and six months. Quality-adjusted life years (QALYs) will be estimated from these measurements, and costs will be compared between groups. The incremental cost-utility ratio will be expressed as cost per QALY, with results also presented as incremental net monetary benefit for different willingness-to-pay values.
The six-month horizon begins at inclusion rather than at the intervention because the time to treatment may differ between the two groups. Consequently, assessments at three and six months from inclusion may occur at different intervals after the intervention in the two groups.
Secondary assessments include treatment completeness, procedure duration, intraoperative complications, pain, analgesic use, symptoms measured using the Higham score and UFS-QoL questionnaire, health-related quality of life, the need for further treatment, healthcare resource use, length of hospital stay, and patient and practitioner satisfaction. A five-year budget impact analysis will also assess scenarios for the national adoption of outpatient hysteroscopic morcellation/aspiration.
The planned sample size is 474 participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operating-room hysteroscopy with resectoscope | Active comparator | Procedure: Operating-room hysteroscopy with resectoscopeParticipants undergo operative hysteroscopy using a resectoscope in the operating room, with general or regional anesthesia according to the usual care pathway and clinical decision. |
| Outpatient hysteroscopic morcellation/aspiration | Experimental | Procedure: Outpatient hysteroscopic morcellation/aspirationParticipants undergo operative hysteroscopy using a morcellation/aspiration system in a dedicated outpatient consultation room, without an operating-room pathway. Analgesia options may include non-steroidal anti-inflammatory medication, local anesthesia, virtual reality and/or an equimolar mixture of oxygen and nitrous oxide, according to participant preference and clinical circumstances. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged 18 years or older.
- One or more intrauterine submucosal fibroids, FIGO types 0, 1 or 2, measuring 2 cm or less, confirmed by diagnostic hysteroscopy; OR one or more intrauterine polyps confirmed by diagnostic hysteroscopy; OR retained pregnancy tissue confirmed by diagnostic hysteroscopy.
- Willingness to participate and provision of written informed consent.
- Willingness to complete follow-up for at least 12 months after the intervention and, when the intervention is delayed after inclusion, for up to 16 months from inclusion.
- Affiliation with or entitlement to a health insurance scheme.
Key exclusion criteria (7 listed)
- Does not wish to undergo surgical treatment.
- Anticoagulant treatment that prevents outpatient operative hysteroscopy.
- Pregnancy or breastfeeding.
- Active pelvic or genital infection.
- Adult under a legal protection measure.
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 |
|---|---|---|
| Operating-room hysteroscopy with resectoscopeA resectoscope is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the examination of the uterus and the treatment of gynecological conditions through the natural passages (vagina, cervix). It provides direct access to the interior of the uterine cavity without the need for an abdominal incision. The procedure is performed in the operating room under general or regional anesthesia. The resectoscope is used for myomectomy, polypectomy, resection of retained trophoblasts or placental remnants, or division of a septum The procedure is performed as follows: 1. Positioning of the patient and anesthesia 2. Insertion of the resectoscope and exploration 3. Surgical phase 4. Removal of the resectoscope and monitoring The procedure is contraindicated in cases of active genital infection | Procedure or surgery | Operating-room hysteroscopy with resectoscope |
| Outpatient hysteroscopic morcellation/aspirationThe therapeutic hysteroscope with fragmentation and aspiration is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the rapid and precise removal of abnormal tissue without the need for incisions. The procedure is performed in a dedicated examination room (clean room). It can be used outside the operating room with or without local anesthesia. Morcellation/aspiration hysteroscopy is indicated for myomectomy, polypectomy, and resection of retained trophoblasts or placental remnants. The procedure is performed as follows: 1. Positioning of the patient, with or without multimodal anesthesia 2. Insertion of the therapeutic fragmentation-aspiration hysteroscope and exploration 3. Surgical phase 4. Removal of the therapeutic fragmentation-aspiration hysteroscope and monitoring The procedure is contraindicated in cases of active genital infection | Procedure or surgery | Outpatient hysteroscopic morcellation/aspiration |
Primary outcome
Incremental cost-utility ratio of outpatient hysteroscopic morcellation/aspiration versus operating-room resectoscopy
Time frame: Six months after inclusion
Cost-utility analysis comparing the two care pathways from a collective perspective. Costs and quality-adjusted life years (QALYs) derived from EQ-5D-5L measurements will be compared between groups. The incremental cost-utility ratio will be expressed as cost per QALY and results will also be presented as incremental net monetary benefit at different willingness-to-pay thresholds.
12 secondary outcomes
Five-year budget impact of national adoption of outpatient hysteroscopic morcellation/aspiration
Time frame: Five-year time horizon
Completeness of the operative hysteroscopy procedure
Time frame: At the end of the procedure
Duration of the operative hysteroscopy procedure
Time frame: During the procedure
Intraoperative complications
Time frame: During the operative procedure
Pain intensity and analgesic use
Time frame: During and at the end of the procedure, immediately after surgery, and at Day 7 after the intervention
Change in symptoms and disease-specific quality of life
Time frame: At inclusion; Day 7, Month 1 and Month 12 after intervention; and Months 3 and 6 after inclusion
Health-related quality of life measured using EQ-5D-5L
Time frame: At inclusion and at Months 3 and 6 after inclusion
Need for further treatment or repeat intervention
Time frame: At Months 1 and 12 after intervention, and Months 3 and 6 after inclusion
Time to treatment, hospital length of stay and healthcare resource use
Time frame: From inclusion through the follow-up period, as applicable
Patient satisfaction with the procedure and care pathway
Time frame: On the day of the procedure and at Day 7 after intervention
Practitioner satisfaction with the procedure and care pathway
Time frame: On the day of the procedure
Acceptability of study participation
Time frame: During recruitment
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Thibault THUBERT study director
Nantes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operating-room hysteroscopy with resectoscope and Outpatient hysteroscopic morcellation/aspiration in people with Uterine Polyps and Uterine Fibroids, run by Nantes University Hospital at 9 sites in France.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 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 9 sites in France. 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 Pr Thibault THUBERT (+33253482443, thibault.thubert@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-utility ratio of outpatient hysteroscopic morcellation/aspiration versus operating-room resectoscopy (time frame: Six months after inclusion). 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 2 Nov 2026.