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

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HIFU (Focal One®)
Sponsored by
EDAP TMS S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring HIFU, High Intensity Focused Ultrasound, DIE, rectal endometriosis, safety profile, Deep invasive endometriosis, Endometriosis, rectum

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU (Focal One®) Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2018
Last Updated
July 30, 2019
Sponsor
EDAP TMS S.A.
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03613298
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EDAP TMS S.A.
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
HIFU, High Intensity Focused Ultrasound, DIE, rectal endometriosis, safety profile, Deep invasive endometriosis, Endometriosis, rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
deep invasive endometriosis (DIE)
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil DUBERNARD, MD PhD
Organizational Affiliation
Hôpital de la Croix Rousse Service de Gynécologie-Obstétrique, Hospices Civils de Lyon, 103, Grande rue de la Croix Rousse 69 004 Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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