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NCT Number: NCT07179419

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

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Djamila BENNAT

CONTACT

[email protected]

+33 472 153 125

Sponsors and collaborators

Lead sponsor

EDAP TMS S.A.

Industry

Registry information

Acronym: ENDO HIFU FU

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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