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Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.

NCT05755958 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-05

No results posted yet for this study

Summary

Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation.

Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.

In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.

Conditions

  • Endometriosis

Interventions

DEVICE

HIFU treatment in rectal Endometriosis

HIFU treatment of rectal endometriosis

DEVICE

SHAM HIFU procedure

SHAM HIFU procedure

Sponsors & Collaborators

  • EDAP TMS S.A.

    lead INDUSTRY

Principal Investigators

  • Gil Dubernard, Pr · EDAP TMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2024-01-23
Completion
2025-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755958 on ClinicalTrials.gov