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RecruitingNCT07179419ENDO HIFU FUUpdated Sep 17, 2025

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

An observational study in Endometriosis, sponsored by EDAP TMS S.A.. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by EDAP TMS S.A. · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Endometriosis

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Keywords

  • HIFU
  • FocalOne
  • Rectal Endometriosis
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 140 is close to the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

EDAP TMS S.A. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-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.

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Hopital de la Croix Rousse
    Lyon, 69004, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07179419
Lead sponsor
EDAP TMS S.A.
Responsible party
Sponsor
First posted
Sep 17, 2025
Start date
Oct 10, 2021
Primary completion
Sep 30, 2029 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Sep 17, 2025

Study contacts

Djamila BENNAT
Contact
affaires-cliniques@edap-tms.com
+33 472 153 125

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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