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

NCT ID: NCT07179419

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-10

Study Completion Date

2029-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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EDAP TMS S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital de la Croix Rousse

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Djamila BENNAT

Role: CONTACT

+33 472 153 125

Facility Contacts

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Gil Pr Dubernard

Role: primary

+334 72 11 80 88

Other Identifiers

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HIFU/F/21.04

Identifier Type: -

Identifier Source: org_study_id

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