Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
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| ClinicalTrials.gov Identifier: NCT03613298 |
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Recruitment Status :
Completed
First Posted : August 3, 2018
Last Update Posted : July 31, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endometriosis | Device: HIFU (Focal One®) | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 21, 2015 |
| Actual Primary Completion Date : | May 2019 |
| Actual Study Completion Date : | May 2019 |
| Arm | Intervention/treatment |
|---|---|
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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. |
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.
Other Name: High-Intensity Focused Ultrasounds |
- 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).
- 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.
- 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
- 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.
- Assessment of Adverse Events during the 6 months follow-up attributable to the technique [ Time Frame: 6 months ]Complications post HIFU treatment.
- 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)
- endometriosis health profile assessment [ Time Frame: 6 months ]self-administrated questionnaire: endometriosis health profile (EHP-5)
- Urinary symptom profile assessment [ Time Frame: 6 months ]self-administrated questionnaire: urinary symptom profile (USP)
- Sexual function assessment [ Time Frame: 6 months ]self-administrated questionnaire: Female Sexual Function Index (FSFI)
- Constipation assessment [ Time Frame: 6 months ]self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)
- Anal continence assessment [ Time Frame: 6 months ]self-administrated questionnaire: Wexner score of anal continence
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| Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | deep invasive endometriosis (DIE) |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613298
| France | |
| Hôpital de la Croix Rousse | |
| Lyon, France, 69004 | |
| 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 |
| Responsible Party: | EDAP TMS S.A. |
| ClinicalTrials.gov Identifier: | NCT03613298 |
| Other Study ID Numbers: |
HIFU/F/13.12 |
| First Posted: | August 3, 2018 Key Record Dates |
| Last Update Posted: | July 31, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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HIFU High Intensity Focused Ultrasound DIE rectal endometriosis |
safety profile Deep invasive endometriosis Endometriosis, rectum |
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Endometriosis |