Back to resultsEvaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis (ENDO-HIFU-R1)
Primary Purpose
Endometriosis, Rectum
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HIFU treatment
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis, Rectum focused on measuring rectal endometriosis, HIFU
Eligibility Criteria
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
Sites / Locations
- CHU de Angers
- Clinique Tivoli-Ducos
- Hôpital BICETRE
- Clinique de Gynécologie
- Hopital de la Croix Rousse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIFU intervention
Arm Description
patients will benefit of an HIFU Treatment of their rectal endometriosis
Outcomes
Primary Outcome Measures
Evaluate the tolerance of rectal endometriosis treatment with HIFU
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
Secondary Outcome Measures
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
EVA symptom Questionnaires
Evaluation of the of quality of life evolution of patients after HIFU treatment
Quality of life questionnaire : MOS- SF-36
Evaluation of the evolution of the nodule's volume
The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
Evaluation of the post-intervention analgesic treatment
The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Wexner
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Kess questionnaires
Evaluation of the sexual symptoms evolution of patients after HIFU treatment
SFSI questionnaire
Evaluation of the urinary symptoms evolution of patients after HIFU treatment
USP questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04494568
Brief Title
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
Acronym
ENDO-HIFU-R1
Official Title
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EDAP TMS S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Rectum
Keywords
rectal endometriosis, HIFU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIFU intervention
Arm Type
Experimental
Arm Description
patients will benefit of an HIFU Treatment of their rectal endometriosis
Intervention Type
Device
Intervention Name(s)
HIFU treatment
Intervention Description
HIFU Treatment of rectal endometriosis
Primary Outcome Measure Information:
Title
Evaluate the tolerance of rectal endometriosis treatment with HIFU
Description
The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
Description
EVA symptom Questionnaires
Time Frame
at 1 month, 3 months and 6 months post-intervention
Title
Evaluation of the of quality of life evolution of patients after HIFU treatment
Description
Quality of life questionnaire : MOS- SF-36
Time Frame
at 1 month, 3 months and 6 months post-intervention,
Title
Evaluation of the evolution of the nodule's volume
Description
The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.
Time Frame
at 6 months
Title
Evaluation of the post-intervention analgesic treatment
Description
The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.
Time Frame
during the fisrt 10 days post treatment.
Title
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Description
Wexner
Time Frame
at 1 month, 3 months and 6 months post-intervention
Title
Evaluation of the digestive symptoms evolution of patients after HIFU treatment
Description
Kess questionnaires
Time Frame
at 1 month, 3 months and 6 months post-intervention
Title
Evaluation of the sexual symptoms evolution of patients after HIFU treatment
Description
SFSI questionnaire
Time Frame
at 1 month, 3 months and 6 months post-intervention
Title
Evaluation of the urinary symptoms evolution of patients after HIFU treatment
Description
USP questionnaire
Time Frame
at 1 month, 3 months and 6 months post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil DUBERNARD, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Angers
City
Angers
Country
France
Facility Name
Clinique Tivoli-Ducos
City
Bordeaux
Country
France
Facility Name
Hôpital BICETRE
City
Le Kremlin-Bicêtre
Country
France
Facility Name
Clinique de Gynécologie
City
Lille
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
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