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

NCT05755958 | Active Not Recruiting

• 1 other identifier: HIFU/F/21.12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Rectal Endometriosis; HIFU; FocalOne; High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.

  The efficacy of HIFU treatment will be assessed by comparing the evolution in the level of acute pelvic pain assessed by Visual Analog Scale (VAS), ranging from 0 (best situation) to 10 (worst situation) at 3 months, to the pre-treatment pain level. The evolution in the HIFU group will be compared to those in the sham intervention group.

  3 months

Secondary Outcomes (11)

• Adverse Events occurrence and comparison between the two groups

  3 months

• Symptoms evolution evaluation

  1 and 3 months

• Evaluation of anal continence

  1 and 3 months

• Evaluation of constipation

  1 and 3 months

• Evaluation of urinary symptoms

  1 and 3 months

Study Arms (2)

HIFU SHAM

SHAM COMPARATOR

The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will not be delivered on the lesion to be treated in a blinded manner. Patients randomized to this arm will received exactly the same procedure as patients in the HIFU group with the exception of the HIFU shots.

Device: SHAM HIFU procedure

HIFU TREATMENT

ACTIVE COMPARATOR

The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will be delivered on the lesion to be treated in a blinded maner.

Device: HIFU treatment in rectal Endometriosis

Interventions

HIFU treatment in rectal Endometriosis DEVICE

HIFU treatment of rectal endometriosis

HIFU TREATMENT

SHAM HIFU procedure DEVICE

SHAM HIFU procedure

HIFU SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EDAP TMS S.A.: lead

Study Sites (9)

Hopital Privé de Provence

Aix-en-Provence, 13080, France

Location

CHU de Angers

Angers, 49000, France

Location

Clinique Tivoli-Ducos

Bordeaux, 33000, France

Location

Chu Estaing

Clermont-Ferrand, 63000, France

Location

Hôpital du Kremlin Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital privé Le Bois

Lille, 59000, France

Location

Hopital de la Croix Rousse

Lyon, 69004, France

Location

Hôpital COCHIN

Paris, 75014, France

Location

CHU Strasbourg

Strasbourg, 67200, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Gil Dubernard, Pr

  EDAP TMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 6, 2023
• Study Start: February 3, 2023
• Primary Completion: January 23, 2024
• Study Completion: July 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

FR (9)