Recruiting NCT07179419

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

— Observational Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Endometriosis. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

Compare the SF36 score assessed before HIFU treatment with that assessed in the long term after HIFU treatment. [Time frame: every year during 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Other

Study locations

France · 1 center

Hopital de la Croix Rousse — Lyon

Identifiers

NCT: NCT07179419 · HIFU/F/21.04

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗