NCT06108167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

November 2, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 28, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

EndometriosisEndometrial cellsRadiofrequencyAnterior abdominalCryotherapy

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gynécologie Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

October 30, 2023

Study Start

May 5, 2023

Primary Completion

November 5, 2023

Study Completion

November 5, 2023

Last Updated

November 2, 2023

Record last verified: 2023-08

Locations