- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494568
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis (ENDO-HIFU-R1)
Rectal endometriosis (RE) induces lesions 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 investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire JOSSAN
- Phone Number: 04.72.15.31.50
- Email: Affaires-Cliniques@edap-tms.com
Study Locations
-
-
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Angers, France
- Recruiting
- CHU de Angers
-
Principal Investigator:
- Philippe DESCAMPS, Dr
-
Bordeaux, France
- Recruiting
- Clinique Tivoli-Ducos
-
Principal Investigator:
- Horace Roman, Pr
-
Le Kremlin-Bicêtre, France
- Recruiting
- Hopital Bicetre
-
Principal Investigator:
- Hervé Fernandez, Pr
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Lille, France
- Not yet recruiting
- Clinique de Gynecologie
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Principal Investigator:
- Pierre Collinet, Pr
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Lyon, France, 69004
- Recruiting
- Hopital de la Croix Rousse
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Principal Investigator:
- Gil Dubernard, Pr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged at least 25 years-old
- Rectal endometriosis in preoperative imaging, without other digestive locations (colon, ileum and small intentine)
- Symptomatic patient refusing hormonal treatment and/or surgery.
- Endometriosic nodule visible on echography with contrast and confirmed in Gadolinium MRI and difusion sequence (according to standardized protocol)
- Nodule with intrarectal protrusion of less than 50% (allowing the positioning of the probe in front of the rectal nodule)
- Distance from the upper pole to the anal margin ≤ 15 cm (measurement by MRI with intra-rectal contrast)
- No curent pregnancy (negative BHCG <72h before the HIFU procedure) and no pregnancy project within 6 months after the HIFU procedure (post-treatment MRI delay)
- Patient agreeing not to change her hormone treatment for the duration of the study.
- Patient accepting the study constraints
- Health insurance affiliated patient or beneficiary of an equivalent coverage
Exclusion Criteria:
- Virgin patient
- Ongoing uro-genital infection
- Anorectal anatomy incompatible with HIFU therapy
- History of segmental rectal resection with mechanical anastomosis, shaving or discoid resection
- Patient with an implant within 1cm of the treatment area (stent, catheter, ESSURE® contraceptive implants).
- Inflammatory colon disease (ulcerative colitis, Crohn's disease and others)
- Latex allergy
- Patient with contraindications to MRI
- Patient with contraindications to Gadolinium injection
- Patient previously treated with HIFU for a rectal endometriotic lesion
- Patient not speaking nor reading French
- Patient deprived of liberty following a legal or administrative decision
- Patient under guardianship or tutelage measure
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 intervention
patients will benefit of an HIFU Treatment of their rectal endometriosis
|
HIFU Treatment of rectal endometriosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the tolerance of rectal endometriosis treatment with HIFU
Time Frame: 6 months
|
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
Time Frame: at 1 month, 3 months and 6 months post-intervention
|
EVA symptom Questionnaires
|
at 1 month, 3 months and 6 months post-intervention
|
Evaluation of the of quality of life evolution of patients after HIFU treatment
Time Frame: at 1 month, 3 months and 6 months post-intervention,
|
Quality of life questionnaire : MOS- SF-36
|
at 1 month, 3 months and 6 months post-intervention,
|
Evaluation of the evolution of the nodule's volume
Time Frame: at 6 months
|
The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
|
at 6 months
|
Evaluation of the post-intervention analgesic treatment
Time Frame: during the fisrt 10 days post treatment.
|
The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
|
during the fisrt 10 days post treatment.
|
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Time Frame: at 1 month, 3 months and 6 months post-intervention
|
Wexner
|
at 1 month, 3 months and 6 months post-intervention
|
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Time Frame: at 1 month, 3 months and 6 months post-intervention
|
Kess questionnaires
|
at 1 month, 3 months and 6 months post-intervention
|
Evaluation of the sexual symptoms evolution of patients after HIFU treatment
Time Frame: at 1 month, 3 months and 6 months post-intervention
|
SFSI questionnaire
|
at 1 month, 3 months and 6 months post-intervention
|
Evaluation of the urinary symptoms evolution of patients after HIFU treatment
Time Frame: at 1 month, 3 months and 6 months post-intervention
|
USP questionnaire
|
at 1 month, 3 months and 6 months post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gil DUBERNARD, Pr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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-20.01
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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