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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613298
• Other study ID #: HIFU/F/13.12
• Status: Completed
• Phase: N/A
• Start date: September 21, 2015
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: EDAP TMS S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
EDAP TMS S.A.	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Effect of HIFU treatment on endometriosic lesion	Ratio calculation between targeted volume and treated volume and Evaluation of HIFU on symptomatology	Day 1
Secondary	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
Secondary	Assessment of Adverse Events during the 6 months follow-up attributable to the technique	Complications post HIFU treatment.	6 months
Secondary	Medical Outcome assessment (Study Short Form-36)	self-administrated questionnaire: French version of the 36-item Short Form Survey (SF-36)	6 months
Secondary	endometriosis health profile assessment	self-administrated questionnaire: endometriosis health profile (EHP-5)	6 months
Secondary	Urinary symptom profile assessment	self-administrated questionnaire: urinary symptom profile (USP)	6 months
Secondary	Sexual function assessment	self-administrated questionnaire: Female Sexual Function Index (FSFI)	6 months
Secondary	Constipation assessment	self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)	6 months
Secondary	Anal continence assessment	self-administrated questionnaire: Wexner score of anal continence	6 months