Clinical trial NCT03613298: Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
Official title: Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) Lesions With Intestinal Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: HIFU
High Intensity Focused Ultrasound
DIE
rectal endometriosis
safety profile
Deep invasive endometriosis
Endometriosis, rectum
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-08-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Targeting of the endometriosic lesion
timeFrame: Day 1
Secondary outcomes:
measure: Anatomical position of the Focal One probe
timeFrame: Day 1
measure: Effect of HIFU treatment on endometriosic lesion
timeFrame: Day 1
measure: Safety of the procedure: assessment of complications during the procedure attributable to the technique
timeFrame: Day 1
measure: Assessment of Adverse Events during the 6 months follow-up attributable to the technique
timeFrame: 6 months
measure: Medical Outcome assessment (Study Short Form-36)
timeFrame: 6 months
measure: endometriosis health profile assessment
timeFrame: 6 months
measure: Urinary symptom profile assessment
timeFrame: 6 months
measure: Sexual function assessment
timeFrame: 6 months
measure: Constipation assessment
timeFrame: 6 months
measure: Anal continence assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hôpital de la Croix Rousse Service de Gynécologie-Obstétrique, Hospices Civils de Lyon, 103, Grande rue de la Croix Rousse 69 004 Lyon
name: Gil DUBERNARD, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: