Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
- Conditions
- Endometriosis
- Interventions
- Device: HIFU (Focal One®)
- Registration Number
- NCT03613298
- Lead Sponsor
- EDAP TMS S.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HIFU (Focal One®) Treatment HIFU (Focal One®) 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.
- Primary Outcome Measures
Name Time Method Targeting of the endometriosic lesion 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).
- Secondary Outcome Measures
Name Time Method Medical Outcome assessment (Study Short Form-36) 6 months self-administrated questionnaire: French version of the 36-item Short Form Survey (SF-36)
Urinary symptom profile assessment 6 months self-administrated questionnaire: urinary symptom profile (USP)
Anatomical position of the Focal One probe Day 1 The objective is to evaluate the position of the probe within the rectum before HIFU treatment.
Safety of the procedure: assessment of complications during the procedure attributable to the technique Day 1 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 6 months Complications post HIFU treatment.
Sexual function assessment 6 months self-administrated questionnaire: Female Sexual Function Index (FSFI)
Effect of HIFU treatment on endometriosic lesion Day 1 Ratio calculation between targeted volume and treated volume and Evaluation of HIFU on symptomatology
endometriosis health profile assessment 6 months self-administrated questionnaire: endometriosis health profile (EHP-5)
Constipation assessment 6 months self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)
Anal continence assessment 6 months self-administrated questionnaire: Wexner score of anal continence
Trial Locations
- Locations (1)
Hôpital de la Croix Rousse
🇫🇷Lyon, France