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

Endometriosis Clinical Trial

— ENDOMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108167
• Other study ID #: 8955
• Status: Recruiting
• Start date: May 5, 2023
• Est. completion date: November 5, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Victor GABRIELE, MD
• Phone: 33 3 69 55 34 04
• Email: victor.gabriele[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: November 5, 2023
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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