Endometrial PolypsRESMONCT02472197
Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy
A study testing Hysteroscopic morcellation and Standard hysteroscopic resection in people with Endometrial Polyps, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical procedure, the intrauterine pathology is resected by a transcervical approach in several fragments using a mono or bipolar cove after distension of the uterine cavity and by endoscopic control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Polyps
- What is being tested?
- Hysteroscopic morcellation and Standard hysteroscopic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jul 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All major patients with single endometrial polyp,
- Confirmed by a diagnostic hysteroscopy
- Greater than or equal to one centimeter in size with no upper size limit
- Patient giving informed consent
- Subject belonging to a social security organisme
Who cannot join
- Ongoing pregnancy or breastfeeding
- Progressive malignant gynecological pathology
- Evolutionary Genital infection
- Suspected malignancy before surgery
- Multiple Polyps
- Polypoid hyperplasia
Show all 11Show fewer
- Associated submucosal myoma
- Person under guardianship
- Patient with contraindication to general anesthesia or spinal anesthesia
- Person in an exclusion period (determined by a previous or ongoing study)
- Inability to give the eprosn informed information (comprehension difficulties ...)
Trial locations and contacts
1 site in 1 country.
About this study
Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical procedure, the intrauterine pathology is resected by a transcervical approach in several fragments using a mono or bipolar cove after distension of the uterine cavity and by endoscopic control. The main risks of this surgery are: uterine perforation and OHIA (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are new intrauterine devices, recently appeared on the French market.
In comparison to classical resectors, morcellators have several theoretical advantages:
Read more
- A smaller instrument diameter with potentially a lower risk of uterine perforation and cervical laceration during the dilatation procedure,
- The use of physiological serum, eliminating the risk of neurological toxicity of glycine,
- The risk of electrical accident is canceled (internal or external burns due to leakage current),
- A decreased risk of air embolism, due to the absence of bubbles' production,
- The instrument is always under visual control, the perforation risk by the active instrument is therefore very limited,
- The vision is not obscured by the fragments or by the bubbles,
- The treatment of pre-ostial pathologies, not always easy in classical resections, could be facilitated,
- the absence of thermal effect, and therefore a potentially lower endometrial aggression, is interesting in women with reproductive desire,
- Absence of chips management, limiting the entry and exit movements in the uterine cavity, improving the vision, reducing the infectious and traumatic risks, specially uterine perforation and air embolism,
- Morcellation could preserve tissues for histological analysis of possible malignancy (compared to techniques using heat, coagulation, vaporization),
- Easy learning in comparison to the time-consuming learning of classical hysteroscopic resection,
- Generated additional cost could be partly amortized by reducing operating time and complications.
It seemed useful to study this new technology.
The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated Bigatti Shaver IBS), Storz®, and a conventional resectoscope.
The secondary purposes were to compare the efficiency, complications and comfort of these techniques.
- Conditions
- Endometrial Polyps
- Being tested
- Hysteroscopic morcellation, Standard hysteroscopic resection
- Keywords
- Endometrial polyp, Hysteroscopic resection, Morcellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic morcellationProcedure or surgery
The endometrial polyp is resected by a transcervical approach. During the procedure, the polyp is placed by suction against the window of the device, then cut by mechanical energy, in chips which are directly aspirated by the device.
Standard hysteroscopic resectionProcedure or surgery
The endometrial polyp is resected by a transcervical approach in several chips using a mono or bipolar cove after distension of the uterine cavity under endoscopic control.
| Study group | Role | What they receive |
|---|---|---|
| morcellation | Experimental | Not described Receives: Procedure: Hysteroscopic morcellation |
| standard resection | Active comparator | Not described Receives: Procedure: Standard hysteroscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morcellation or resection time (minutes)
Measured: From the cervical dilatation just before introducing the operative device until removal of the operative device assessed up to 25 minutes
Secondary outcomes (7)
The completeness of resection or not,
Measured: 10 weeks after surgery
The total operating time (in minutes):
Measured: from the beginning of diagnostic hysteroscopy to the end of operative hysteroscopy resection and removal of the operative device, assessed up to 25 minutes
The amount of serum used (mL)
Measured: At the end of surgery
Perioperative complications,
Measured: 10 weeks after surgery
The quality of vision defined by the operator on a scale of 0 to 5,
Measured: At the end of surgery
Persistence or not of the disease
evaluated by hysteroscopy
Measured: 10 weeks after surgery
The occurrence of secondary adhesions
Measured: 10 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GARBIN, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472197
- Sponsor's protocol ID
- 6043
- Acronym
- RESMO
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16.
PubMed 32681995
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy
- ClinicalTrials.gov ID
- NCT02472197
- Acronym / sponsor ID
- RESMO / 6043
- Conditions
- Endometrial Polyps
- Keywords
- Endometrial polyp, Hysteroscopic resection, Morcellation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Jun 2015 (estimated)
- 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.
Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical procedure, the intrauterine pathology is resected by a transcervical approach in several fragments using a mono or bipolar cove after distension of the uterine cavity and by endoscopic control. The main risks of this surgery are: uterine perforation and OHIA (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are new intrauterine devices, recently appeared on the French market.
In comparison to classical resectors, morcellators have several theoretical advantages:
- A smaller instrument diameter with potentially a lower risk of uterine perforation and cervical laceration during the dilatation procedure,
- The use of physiological serum, eliminating the risk of neurological toxicity of glycine,
- The risk of electrical accident is canceled (internal or external burns due to leakage current),
- A decreased risk of air embolism, due to the absence of bubbles' production,
- The instrument is always under visual control, the perforation risk by the active instrument is therefore very limited,
- The vision is not obscured by the fragments or by the bubbles,
- The treatment of pre-ostial pathologies, not always easy in classical resections, could be facilitated,
- the absence of thermal effect, and therefore a potentially lower endometrial aggression, is interesting in women with reproductive desire,
- Absence of chips management, limiting the entry and exit movements in the uterine cavity, improving the vision, reducing the infectious and traumatic risks, specially uterine perforation and air embolism,
- Morcellation could preserve tissues for histological analysis of possible malignancy (compared to techniques using heat, coagulation, vaporization),
- Easy learning in comparison to the time-consuming learning of classical hysteroscopic resection,
- Generated additional cost could be partly amortized by reducing operating time and complications.
It seemed useful to study this new technology.
The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated Bigatti Shaver IBS), Storz®, and a conventional resectoscope.
The secondary purposes were to compare the efficiency, complications and comfort of these techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morcellation | Experimental | Procedure: Hysteroscopic morcellation |
| standard resection | Active comparator | Procedure: Standard hysteroscopic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All major patients with single endometrial polyp,
- Confirmed by a diagnostic hysteroscopy
- Greater than or equal to one centimeter in size with no upper size limit
- Patient giving informed consent
- Subject belonging to a social security organisme
Key exclusion criteria (11 listed)
- Ongoing pregnancy or breastfeeding
- Progressive malignant gynecological pathology
- Evolutionary Genital infection
- Suspected malignancy before surgery
- Multiple Polyps
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 |
|---|---|---|
| Hysteroscopic morcellationThe endometrial polyp is resected by a transcervical approach. During the procedure, the polyp is placed by suction against the window of the device, then cut by mechanical energy, in chips which are directly aspirated by the device. | Procedure or surgery | morcellation |
| Standard hysteroscopic resectionThe endometrial polyp is resected by a transcervical approach in several chips using a mono or bipolar cove after distension of the uterine cavity under endoscopic control. | Procedure or surgery | standard resection |
Primary outcome
Morcellation or resection time (minutes)
Time frame: From the cervical dilatation just before introducing the operative device until removal of the operative device assessed up to 25 minutes
7 secondary outcomes
The completeness of resection or not,
Time frame: 10 weeks after surgery
The total operating time (in minutes):
Time frame: from the beginning of diagnostic hysteroscopy to the end of operative hysteroscopy resection and removal of the operative device, assessed up to 25 minutes
The amount of serum used (mL)
Time frame: At the end of surgery
Perioperative complications,
Time frame: 10 weeks after surgery
The quality of vision defined by the operator on a scale of 0 to 5,
Time frame: At the end of surgery
Persistence or not of the disease
Time frame: 10 weeks after surgery
The occurrence of secondary adhesions
Time frame: 10 weeks after surgery
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 19 Dec 2025.
- Results publication: PubMed 32681995Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16.
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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.
Olivier GARBIN, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic morcellation and Standard hysteroscopic resection in people with Endometrial Polyps, run by University Hospital, Strasbourg, France at 1 site 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 11 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 19 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 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?
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?
Morcellation or resection time (minutes) (time frame: From the cervical dilatation just before introducing the operative device until removal of the operative device assessed up to 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02472197, which also lists 1 linked publication.
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 19 Dec 2025.