Uterine FibroidsVAPOHYSTERONCT05078307
Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
A study testing OHR VS OHV in people with Uterine Fibroids, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- OHR VS OHV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2021to 17 May 2024
- 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
- Patient at least 18 years old.
- Non-pregnant patient
- A patient who had an ultrasound confirming the presence of a uterine fibroid to be treated less than 6 cm.
- Patient who had a diagnostic hysteroscopy confirming the presence of a uterine fibroid to be treated of type 0, 1 or 2 according to the FIGO classification.
- Patient presenting an indication for intra uterine fibroid resection (bleeding, fertility problems) by operative hysteroscopy.
- Patient having agreed to participate in the study and having signed an informed consent.
Who cannot join
- Minor patient
- Patient not affiliated to a social security system
- Persons benefiting from special protection: by virtue of articles L1121-5 to L1121-8 of the Public Health Code: pregnant or breast-feeding women, minors, adults under guardianship or curatorship, persons deprived of liberty.
- Patient refusing to sign the consent or unable to receive the information necessary to give informed consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-Rhone, 13354
Marjorie Saccone, marjorie.saccone@ap-hm.fr
About this study
Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique.
This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months.
The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.
- Conditions
- Uterine Fibroids
- Being tested
- OHR VS OHV
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHR VS OHVProcedure or surgery
Control group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid.
Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid.
| Study group | Role | What they receive |
|---|---|---|
| OHR System | Active comparator | Use of the OHR system to perform an operative hysteroscopy by resection of the fibroid. Receives: Procedure: OHR VS OHV |
| OHV System | Experimental | Use of the OHV system to perform an operative hysteroscopy by vaporization of the fibroid. Receives: Procedure: OHR VS OHV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time expressed in minutes
Measured: Baseline
Secondary outcomes (6)
The amount of distention fluid used during operative hysteroscopy
Measured by collection of the distention fluid pockets at the end of the procedure
Measured: Baseline
Resection time
Time estimated in cm3/min based on ultrasound measurement of the volume of the myoma involved in the resection preoperatively and postoperatively, related to the operative time
Measured: Baseline
Complication rate during operative hysteroscopy
Cervical tear rate and Rate of uterine perforations
Measured: Baseline
The rate of discontinuation of the operative hysteroscopy before complete resection
Rate of discontinuation because of uterine perforations, operative time greater than 60 minutes, quantity of distension fluid greater than 9 liters, deficit of distension fluid greater than 1 liter, per operative haemorrhage
Measured: Baseline
The rate of postoperative synechiae in patients of childbearing age.
Rate of postoperative synechiae diagnosed at follow-up hysteroscopy in patients of childbearing age.
Measured: between 6 and 8 weeks after the operation
Operative pain
Operative pain evaluated by a visual analog scale (0-100mm). If the patient has a score of 0, it means that he/she has no pain. The higher the value, the more intense the pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start25 Sep 2021
- Primary completion17 Nov 2023 (estimated)
- Study completion17 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Director, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078307
- Sponsor's protocol ID
- 2021-09
- Other IDs
- IDRCB
- Acronym
- VAPOHYSTERO
- Status last verified
- Jul 2023
- First submitted
- 15 Sep 2021
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
- ClinicalTrials.gov ID
- NCT05078307
- Acronym / sponsor ID
- VAPOHYSTERO / 2021-09
- Conditions
- Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 17 Nov 2023 (estimated)
- Study completion
- 17 May 2024 (estimated)
- First posted
- 14 Oct 2021 (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.
Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique.
This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months.
The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OHR System | Active comparator | Procedure: OHR VS OHVUse of the OHR system to perform an operative hysteroscopy by resection of the fibroid. |
| OHV System | Experimental | Procedure: OHR VS OHVUse of the OHV system to perform an operative hysteroscopy by vaporization of the fibroid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient at least 18 years old.
- Non-pregnant patient
- A patient who had an ultrasound confirming the presence of a uterine fibroid to be treated less than 6 cm.
- Patient who had a diagnostic hysteroscopy confirming the presence of a uterine fibroid to be treated of type 0, 1 or 2 according to the FIGO classification.
- Patient presenting an indication for intra uterine fibroid resection (bleeding, fertility problems) by operative hysteroscopy.
Key exclusion criteria (4 listed)
- Minor patient
- Patient not affiliated to a social security system
- Persons benefiting from special protection: by virtue of articles L1121-5 to L1121-8 of the Public Health Code: pregnant or breast-feeding women, minors, adults under guardianship or curatorship, persons deprived of liberty.
- Patient refusing to sign the consent or unable to receive the information necessary to give informed consent.
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 |
|---|---|---|
| OHR VS OHVControl group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid. Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid. | Procedure or surgery | OHR System, OHV System |
Primary outcome
Operative time
Time frame: Baseline
Operative time expressed in minutes
6 secondary outcomes
The amount of distention fluid used during operative hysteroscopy
Time frame: Baseline
Resection time
Time frame: Baseline
Complication rate during operative hysteroscopy
Time frame: Baseline
The rate of discontinuation of the operative hysteroscopy before complete resection
Time frame: Baseline
The rate of postoperative synechiae in patients of childbearing age.
Time frame: between 6 and 8 weeks after the operation
Operative pain
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- 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. This study is not recruiting at the moment.
François CREMIEUX, Director study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHR VS OHV in people with Uterine Fibroids, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aubert Agostini, MD/PhD (04 91 38 37 87 ext. +33, aubert.agostini@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Baseline). 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 27 Jul 2023.