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

Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) Lesions With Intestinal Involvement

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Device: HIFU (Focal One®)

Detailed Description

20 Subjects with deep invasive endometriosis (DIE) will receive the HIFU treatment with Focal One® device.

Subjects harboring an isolated recto-sigmoid 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. Succession of HIFU exposure will be then used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae to prevent risk of fistulae.

Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and at 1 and 6 months after HIFU procedure. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hopital de la Croix Rousse

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:

• 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

Exclusion Criteria:

• 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

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 (Focal One®) Treatment; 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®); 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.; Other Names: High-Intensity Focused Ultrasounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical position of the Focal One probe	The objective is to evaluate the position of the probe within the rectum before HIFU treatment.	Day 1
Effect of HIFU treatment on endometriosic lesion	Ratio calculation between targeted volume and treated volume and Evaluation of HIFU on symptomatology	Day 1
Safety of the procedure: assessment of complications during the procedure attributable to the technique	Complications during HIFU treatment attributable to the HIFU energy deposit or the Focal One are described here.	Day 1
Assessment of Adverse Events during the 6 months follow-up attributable to the technique	Complications post HIFU treatment.	6 months
Medical Outcome assessment (Study Short Form-36)	self-administrated questionnaire: French version of the 36-item Short Form Survey (SF-36)	6 months
endometriosis health profile assessment	self-administrated questionnaire: endometriosis health profile (EHP-5)	6 months
Urinary symptom profile assessment	self-administrated questionnaire: urinary symptom profile (USP)	6 months
Sexual function assessment	self-administrated questionnaire: Female Sexual Function Index (FSFI)	6 months
Constipation assessment	self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)	6 months
Anal continence assessment	self-administrated questionnaire: Wexner score of anal continence	6 months

Collaborators and Investigators

• Sponsor: EDAP TMS S.A.
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: High Intensity Focused Ultrasound; HIFU; DIE; rectal endometriosis; safety profile; Deep invasive endometriosis; Endometriosis, rectum
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: HIFU/F/13.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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