ENDOMET: Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06108167
Collaborator
(none)
29
1
6
4.8

Study Details

Study Description

Brief Summary

Endometriosis is a common condition affecting 10% of women. It is characterized by the presence of ectopic endometrial cells. This pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. Rarely, these lesions are found outside the pelvis, and even more exceptionally in the abdominal wall (in 0.03 to 1% of cases).

Cryotherapy has already been used for many years to treat soft tissue tumors (kidney and prostate tumors). It has also been successfully used by interventional radiologists to treat parietal desmoid tumors. After discussions with radiologists, given the similarity of location and extension of wall endometriosis lesions with desmoid tumours, the successes observed, and the scarcity of studies in the literature, it seemed appropriate to the investigators to study this new therapy.

The aim of this study was to investigate the efficacy of cryotherapy on parietal endometriosis lesions.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    29 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars
    Actual Study Start Date :
    May 5, 2023
    Anticipated Primary Completion Date :
    Nov 5, 2023
    Anticipated Study Completion Date :
    Nov 5, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of cryotherapy on parietal endometriosis lesions was assessed using the a visual analogue scale (VAS) ranging from 0 to 10. [Before and 6 months after the cryotherapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.

    • Subject not objecting to the reuse of their data for the purposes of this research

    Exclusion Criteria:
    • Subject having expressed its opposition to the reuse of its data for scientific research purposes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Gynécologie Obstétrique - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06108167
    Other Study ID Numbers:
    • 8955
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Nov 2, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 2, 2023