Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.

NCT03613298 | Completed

• 1 other identifier: HIFU/F/13.12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Deep invasive endometriosis (DIE) includes lesions of the rectosigmoid. Theses lesions are 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 trial is to evaluate the ability of the Focal One® HIFU device to detect and target posterior DIE lesions with intestinal involvement. The secondary objectives are to perform a HIFU lesion, to evaluate morphological modifications of the nodule in post-therapeutic imaging scans, to assess evolution of gynecological symptoms, intestinal symptoms, and patients' quality of life after treatment by HIFU and to collect safety data.

Conditions

Endometriosis

Keywords

HIFU; High Intensity Focused Ultrasound; DIE; rectal endometriosis; safety profile; Deep invasive endometriosis; Endometriosis, rectum

Outcome Measures

Primary Outcomes (1)

• Targeting of the endometriosic lesion

  The main criterion of evaluation will lie on the targeting of the Endometriosic lesion with the Focal One® probe. Measure of the volume of the Endometriosic lesion to treat: targeted volume (estimation from the measures of the length, the height and the width of the nodule).

  Day 1

Secondary Outcomes (10)

• Anatomical position of the Focal One probe

  Day 1

• Effect of HIFU treatment on endometriosic lesion

  Day 1

• Safety of the procedure: assessment of complications during the procedure attributable to the technique

  Day 1

• Assessment of Adverse Events during the 6 months follow-up attributable to the technique

  6 months

• Medical Outcome assessment (Study Short Form-36)

  6 months

Study Arms (1)

HIFU (Focal One®) Treatment

EXPERIMENTAL

Subjects harboring an isolated recto-sigmoid deep invasive endometriosis (DIE) lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to: * Evaluate its ability to locate and assess the volume of the endometriosic lesion * Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule. Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and 1 and 6 months after HIFU. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.

Device: HIFU (Focal One®)

Interventions

HIFU (Focal One®) DEVICE

Endometriosic lesion localization and HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using sonography, pelvic MRI and a transrectal sonography data. Once the pre-defined lesion will be located with Focal One device, succession of HIFU exposure will then be used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae.

Also known as: High-Intensity Focused Ultrasounds

HIFU (Focal One®) Treatment

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: deep invasive endometriosis (DIE)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 25 years
• Isolated recto-sigmoid DIE lesion, with no other endometriosis location on imaging examination (intestinal, urinary or ovarian), the persistence of symptoms despite hormonal treatment and therefore consideration for surgical management.
• Localization of endometriosic lesion described by US, confirmed by MRI
• Negative urinary pregnancy test and No intention to get pregnant during the following 6 months
• Affiliated to the French Social Security System

You may not qualify if:

• Hormonal treatment of endometriosis by Luteinizing Hormone Releasing Hormone agonist (LHRH analogs) of less than 3 months
• Breastfeeding female
• Uro-genital infection in progress (the infection has to be treated before HIFU treatment)
• Anatomical abnormality of the rectum
• Anterior surgery at the level of the anus or rectum
• Presence of an implant (stent, catheter, contraceptive implant) located less than 1 cm from the treatment area.
• History of intestinal inflammatory pathology
• Allergy to latex
• Female with a medical contraindication on MRI
• Female with a medical contraindication to Sonovue® injection
• Female not able to understand the objectives of the study
• Legal person protected by law

Sponsors & Collaborators

• EDAP TMS S.A.: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, 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, MD PhD

  Hôpital de la Croix Rousse Service de Gynécologie-Obstétrique, Hospices Civils de Lyon, 103, Grande rue de la Croix Rousse 69 004 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

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 3, 2018
• Study Start: September 21, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)