Hysteroscopic treatment of uterine fibroids using vaporization
Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
This study is testing a new way to treat uterine fibroids using vaporization to see if it can make the procedure quicker compared to the traditional method for women over 18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Bouches-du-Rhone) |
| Trial ID | NCT05078307 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new hysteroscopic technique for treating submucosal uterine fibroids, comparing the traditional resection method with a vaporization approach. It aims to determine if the vaporization technique can reduce the operative time required for the procedure. Women over 18 years old with confirmed uterine fibroids will be randomly assigned to either the vaporization or resection group after providing informed consent. The study is conducted at a single center in Marseille.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with diagnosed submucosal uterine fibroids less than 6 cm requiring operative hysteroscopy.
Not a fit: Patients who are minors, pregnant, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to shorter surgery times and potentially improved outcomes for women undergoing treatment for uterine fibroids.
How similar studies have performed: There are few comparative studies on this technique, indicating that while it is a novel approach, its effectiveness is not yet well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Marseille, Bouches-du-Rhone
- Assistance Publique Hôpitaux Marseille — Marseille, Bouches-du-Rhone, France (Recruiting)
Study contacts
- Study coordinator: Aubert Agostini, MD/PhD
- Email: aubert.agostini@ap-hm.fr
- Phone: 04 91 38 37 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.