Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis (ENDO-HIFU-R1)

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.

The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis, Rectum
• Intervention / Treatment: Device: HIFU treatment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire JOSSAN; Phone Number: 04.72.15.31.50; Email: Affaires-Cliniques@edap-tms.com

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU de Angers
    • Principal Investigator: Philippe DESCAMPS, Dr
  • Bordeaux, France
    • Recruiting
    • Clinique TIVOLI-DUCOS
    • Principal Investigator: Horace Roman, Pr
  • Le Kremlin-Bicêtre, France
    • Recruiting
    • Hôpital Bicêtre
    • Principal Investigator: Hervé Fernandez, Pr
  • Lille, France
    • Not yet recruiting
    • Clinique de Gynecologie
    • Principal Investigator: Pierre Collinet, Pr
  • Lyon, France, 69004
    • Recruiting
    • Hopital de la croix rousse
    • Principal Investigator: Gil Dubernard, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients aged at least 25 years-old
• Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
• Symptomatic patient refusing hormonal treatment and/or surgery.
• Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
• Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
• Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)
• No curent pregnancy (negative BHCG <72h before the HIFU procedure) and no pregnancy project within 6 months after the HIFU procedure (post-treatment MRI delay)
• Patient agreeing not to change her hormone treatment for the duration of the study.
• Patient accepting the study constraints
• Health insurance affiliated patient or beneficiary of an equivalent coverage

Exclusion Criteria:

• Virgin patient
• Ongoing uro-genital infection
• Anorectal anatomy incompatible with HIFU therapy
• History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
• Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
• Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)
• Latex allergy
• Patient with contraindications to MRI
• Patient with contraindications to Gadolinium injection
• Patient previously treated with HIFU for a rectal endometriotic lesion
• Patient not speaking nor reading French
• Patient deprived of liberty following a legal or administrative decision
• Patient under guardianship or tutelage measure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIFU intervention; patients will benefit of an HIFU Treatment of their rectal endometriosis	Device: HIFU treatment; HIFU Treatment of rectal endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the tolerance of rectal endometriosis treatment with HIFU	The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment	EVA symptom Questionnaires	at 1 month, 3 months and 6 months post-intervention
Evaluation of the of quality of life evolution of patients after HIFU treatment	Quality of life questionnaire : MOS- SF-36	at 1 month, 3 months and 6 months post-intervention,
Evaluation of the evolution of the nodule's volume	The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.	at 6 months
Evaluation of the post-intervention analgesic treatment	The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.	during the fisrt 10 days post treatment.
Evaluation of the digestive symptoms evolution of patients after HIFU treatment	Wexner	at 1 month, 3 months and 6 months post-intervention
Evaluation of the digestive symptoms evolution of patients after HIFU treatment	Kess questionnaires	at 1 month, 3 months and 6 months post-intervention
Evaluation of the sexual symptoms evolution of patients after HIFU treatment	SFSI questionnaire	at 1 month, 3 months and 6 months post-intervention
Evaluation of the urinary symptoms evolution of patients after HIFU treatment	USP questionnaire	at 1 month, 3 months and 6 months post-intervention

Collaborators and Investigators

• Sponsor: EDAP TMS S.A.
• Investigators: Principal Investigator: Gil DUBERNARD, Pr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: rectal endometriosis, HIFU
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: HIFU-F-20.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No