Evaluation of the Long-term Therapeutic Effect of High-In... | NCT07179419

Studies
Evaluation of the Long-term Therapeutic Effect of High-Intensity Focused Ultrasound (HIFU) Treatment in Patients With Rectal Endometriosis

NCT07179419

Sponsor

EDAP TMS S.A.

Status

Recruiting

Last Update Posted

Sep 17, 2025Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Endometriosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2021Actual

Primary Completion Date

Sep 30, 2029Estimated

Completion Date

Sep 30, 2029Estimated

First Submitted Date

Sep 11, 2025

First Submission Date that Met QC Criteria

Sep 16, 2025

First Posted Date

Sep 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This study evaluates the long-term effects of HIFU treatment on endometriosis symptoms in patients who have received this treatment. The patients included will have participated in the following studies: HIFU/F/13.12, ENDO HIFU R1, and ENDO HIFU R2.

Patients will complete an electronic questionnaire and receive a telephone call to monitor these parameters.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment.		every year during 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Djamila BENNAT	Contact	+33 472 153 125		affaires-cliniques@edap-tms.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital de la Croix Rousse	Recruiting	Lyon		69004	France

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided