- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613298
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69004
- Hopital de la Croix Rousse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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:
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. |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Targeting of the endometriosic lesion
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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
Time Frame: 6 months
|
Complications post HIFU treatment.
|
6 months
|
Medical Outcome assessment (Study Short Form-36)
Time Frame: 6 months
|
self-administrated questionnaire: French version of the 36-item Short Form Survey (SF-36)
|
6 months
|
endometriosis health profile assessment
Time Frame: 6 months
|
self-administrated questionnaire: endometriosis health profile (EHP-5)
|
6 months
|
Urinary symptom profile assessment
Time Frame: 6 months
|
self-administrated questionnaire: urinary symptom profile (USP)
|
6 months
|
Sexual function assessment
Time Frame: 6 months
|
self-administrated questionnaire: Female Sexual Function Index (FSFI)
|
6 months
|
Constipation assessment
Time Frame: 6 months
|
self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)
|
6 months
|
Anal continence assessment
Time Frame: 6 months
|
self-administrated questionnaire: Wexner score of anal continence
|
6 months
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIFU/F/13.12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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