NCT07179419

Brief Summary

Evaluate the long-term effects of HIFU treatment for rectal endometriosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
41mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress57%
Oct 2021Sep 2029

Study Start

First participant enrolled

October 10, 2021

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

8 years

First QC Date

September 11, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

HIFUFocalOneRectal Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment.

    every year during 5 years

Eligibility Criteria

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

All patients who received HIFU treatment for rectal endometriosis as part of studies HIFU/F/13.12, HIFU/F/20.01, and HIFU/F/21.12.

You may qualify if:

  • Patients who have been treated with HIFU for rectal endometriosis included in study HIFU/F/13.12, study HIFU/F/20.01 (ENDO HIFU R1) or study HIFU/F/21.12 (ENDO HIFU R2)
  • Agreeing to participate in the study
  • Patients with internet access so that they can complete the questionnaires electronically.

You may not qualify if:

  • Patients deprived of their liberty following a judicial or administrative decision,
  • Patients under guardianship or conservatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la Croix Rousse

Lyon, 69004, 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
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 17, 2025

Study Start

October 10, 2021

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations