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Clinical Trials in France / NCT05755958
Active, not recruiting Not applicable

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

NCT05755958 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-02-03
Last updated
2025-06-05

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

HIFU treatment in rectal EndometriosisSHAM HIFU procedure

HIFU treatment in rectal Endometriosis: HIFU treatment of rectal endometriosis

SHAM HIFU procedure: SHAM HIFU procedure

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient 18 years of age or older, * Rectal endometriosis on preoperative imaging with no other digestive location, * Symptomatic patient (Acute pelvic pain \> 3), in failure of drug treatment, * Endometriotic lesion visible on ultrasound and confirmed on MRI, * Centralized MRI, reviewed and validated by the MRI review committee, * No current pregnancy and no pregnancy plan during the study period, * Patient agreeing not to change her hormonal treatment throughout the study period, * Patient accepting the constraints of follow-up defined in the framework of the study, * Patient affiliated to French health insurance. Exclusion Criteria: * Ongoing urogenital infection, * Anorectal anatomy incompatible with HIFU treatment, * Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible, * History of segmental rectal resection or discoid resection, * Patient with an implant located less than 1 cm from the treatment area, * Inflammatory disease of the colon, * Allergy to latex, * No scheduled endometriosis procedures during study follow-up, * Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate * Patient with contraindications to MRI, * Patient who has already received HIFU treatment for a rectal endometriotic lesion, * Patient who does not speak or read French, * Patient deprived of liberty following a judicial or administrative decision, * Patient in labor or nursing, * Patient under guardianship or curatorship

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Hopital Privé de Provence Aix-en-Provence France
CHU de Angers Angers France
Clinique Tivoli-Ducos Bordeaux France
Chu Estaing Clermont-Ferrand France
Hôpital du Kremlin Bicetre Le Kremlin-Bicêtre France
Hôpital privé Le Bois Lille France
Hopital de la Croix Rousse Lyon France
Hôpital COCHIN Paris France
CHU Strasbourg Strasbourg France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05755958 on ClinicalTrials.gov ↗ ← All trials in France