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

NCT04494568 | Completed DMC

• 1 other identifier: HIFU-F-20.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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

Conditions

Endometriosis, Rectum

Keywords

rectal endometriosis, HIFU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Evaluation of the gynecological symptoms evolution of patients after HIFU treatment

  at 1 month, 3 months and 6 months post-intervention

• Evaluation of the of quality of life evolution of patients after HIFU treatment

  at 1 month, 3 months and 6 months post-intervention,

• Evaluation of the evolution of the nodule's volume

  at 6 months

• Evaluation of the post-intervention analgesic treatment

  during the fisrt 10 days post treatment.

• Evaluation of the digestive symptoms evolution of patients after HIFU treatment

  at 1 month, 3 months and 6 months post-intervention

Study Arms (1)

HIFU intervention

EXPERIMENTAL

patients will benefit of an HIFU Treatment of their rectal endometriosis

Device: HIFU treatment

Interventions

HIFU treatment DEVICE

HIFU Treatment of rectal endometriosis

HIFU intervention

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EDAP TMS S.A.: lead

Study Sites (5)

CHU de Angers

Angers, France

Location

Clinique Tivoli-Ducos

Bordeaux, France

Location

Hôpital BICETRE

Le Kremlin-Bicêtre, France

Location

Clinique de Gynécologie

Lille, France

Location

Hopital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Dubernard G, Maissiat E, Legendre G, Dennis T, Capmas P, Warembourg S, Descamps P, Chavrier F, Roman H, Fernandez H, Nguyen-Ba E, Merlot B, Rousset P, Lafon C, Philip CA. Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients. Hum Reprod. 2024 Aug 1;39(8):1673-1683. doi: 10.1093/humrep/deae127.

  PMID: 38914481 DERIVED

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

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 31, 2020
• Study Start: August 27, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

FR (5)