- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05755958
Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms. (ENDO-HIFU-R2)
Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
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.
In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire JOSSAN
- Phone Number: +33472153175
- Email: affaires-cliniques@edap-tms.com
Study Locations
-
-
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Aix-en-Provence, France, 13080
- Recruiting
- Hopital Privé de Provence
-
Principal Investigator:
- Jean Philippe Estrade, Dr
-
Angers, France, 49000
- Recruiting
- CHU de Angers
-
Principal Investigator:
- Guillaume Legendre, Dr
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Bordeaux, France, 33000
- Recruiting
- Clinique Tivoli-Ducos
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Principal Investigator:
- Thomas Dennis, Dr
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Clermont-Ferrand, France, 63000
- Recruiting
- Chu Estaing
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Principal Investigator:
- Michel Canis, Pr
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Le Kremlin-Bicêtre, France, 94270
- Recruiting
- Hôpital du Kremlin Bicetre
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Principal Investigator:
- Perrine Capmas, Dr
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Lille, France, 59000
- Recruiting
- Hôpital privé Le Bois
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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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Sub-Investigator:
- Gil Dubernard, Pr
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Principal Investigator:
- Charles-André Philip, dr
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Paris, France, 75014
- Recruiting
- Hôpital COCHIN
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Principal Investigator:
- Louis Marcellin, Dr
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Strasbourg, France, 67200
- Recruiting
- CHU Strasbourg
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Principal Investigator:
- Emilie Faller, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient 18 years of age or older,
- Rectal endometriosis on preoperative imaging with no other digestive location,
- Symptomatic patient (Acute pelvic pain > 3), in failure of drug treatment,
- Endometriotic lesion visible on ultrasound and confirmed on MRI,
- Centralized MRI, reviewed and validated by the MRI review committee,
- No current pregnancy and no pregnancy plan during the study period,
- Patient agreeing not to change her hormonal treatment throughout the study period,
- Patient accepting the constraints of follow-up defined in the framework of the study,
- Patient affiliated to French health insurance.
Exclusion Criteria:
- Ongoing urogenital infection,
- Anorectal anatomy incompatible with HIFU treatment,
- Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
- History of segmental rectal resection or discoid resection,
- Patient with an implant located less than 1 cm from the treatment area,
- Inflammatory disease of the colon,
- Allergy to latex,
- No scheduled endometriosis procedures during study follow-up,
- Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
- Patient with contraindications to MRI,
- Patient who has already received HIFU treatment for a rectal endometriotic lesion,
- Patient who does not speak or read French,
- Patient deprived of liberty following a judicial or administrative decision,
- Patient in labor or nursing,
- Patient under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: HIFU SHAM
The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table. An endorectal probe is inserted in the patient's rectum. The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment. After identification of the treatment area, HIFU shots will not be delivered on the lesion to be treated in a blinded manner. Patients randomized to this arm will received exactly the same procedure as patients in the HIFU group with the exception of the HIFU shots. |
SHAM HIFU procedure
|
Active Comparator: HIFU TREATMENT
The patient placed in the right lateral decubitus position under general anesthesia or spinal anesthesia on the operating table.
An endorectal probe is inserted in the patient's rectum.
The probe includes an imaging transducer to visualize the endometriosis lesions and locate areas to be treated and an ultrasound therapy transducer to administer the HIFU treatment.
After identification of the treatment area, HIFU shots will be delivered on the lesion to be treated in a blinded maner.
|
HIFU treatment of rectal endometriosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
Time Frame: 3 months
|
The efficacy of HIFU treatment will be assessed by comparing the evolution in the level of acute pelvic pain assessed by Visual Analog Scale (VAS), ranging from 0 (best situation) to 10 (worst situation) at 3 months, to the pre-treatment pain level.
The evolution in the HIFU group will be compared to those in the sham intervention group.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events occurrence and comparison between the two groups
Time Frame: 3 months
|
Occurrence of adverse events during the 3 months of post-intervention follow-up will be evaluated in each group.
|
3 months
|
Symptoms evolution evaluation
Time Frame: 1 and 3 months
|
The Visual Analog Scale (VAS) symptoms questionnaire to assess gynecologic, digestive, urinary and general symptoms though 15 different visual scales ranging from 0 (representing no symptom) to 10 (representing the worst patient feeling). Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group. |
1 and 3 months
|
Evaluation of anal continence
Time Frame: 1 and 3 months
|
The Wexner total score ranges from 0 to 23 points corresponding to the sum of the 6 questions. Anal incontinence is considered as mild for a total score from 0 to 4, moderate when ranging from 5 to 9, important from 10 to 16, and considered as severe if equal to 16 or higher. Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group. |
1 and 3 months
|
Evaluation of constipation
Time Frame: 1 and 3 months
|
The KESS (Knowles-Eccersley-Scott Symptom) question is composed of the sum of 11 questions evaluating constipation. The total score ranges from 0 to 39 points corresponding to a total constipation status. Constipation is generally defined as a score above 10. Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group. |
1 and 3 months
|
Evaluation of urinary symptoms
Time Frame: 1 and 3 months
|
USP (Urinary Symptoms Profile) is a questionnaire that assesses urinary symptoms. It includes 13 questions grouped in 3 domains:
The USP total score is the sum of all the 13 answers and ranges from 0 to 39 points, where 39 corresponds to the worst situation. Urinary dysfunction is generally defined as a score above 10. Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group. |
1 and 3 months
|
Evaluation of sexual fonction
Time Frame: 1 and 3 months
|
FSFI (Female Sexual Function Index scoring) is a validated questionnaire, including 19 items, which assesses different domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) in addition to providing an overall score regarding sexual function. FSFI total score ranges from 2 (worst situation) to 36 (best situation). Symptoms level will be collected before treatment and at 1 and 3 months after treatment. The symptoms' evolution in the HIFU group will be compared to those in the sham intervention group. |
1 and 3 months
|
Quality of life evoluation
Time Frame: 1 and 3 months
|
The questionnaire for the Quality of life evaluation is MOS-SF-36 (Medical Outcomes Study Short Form 36 item Health survey). The MOS-SF-36 questionnaire consists of 36 questions which are divided into 8 different domains. Each domain is represented by the average of several questions (after recoding). Two scores, physical and mental, are then calculated. The maximum value of 100 corresponds to an optimal quality of life as described by the patient and zero the worst situation. Quality of life will be collected before treatment and at 1 and 3 months after treatment. The quality of life evolution in the HIFU group will be compared to those in the sham intervention group. |
1 and 3 months
|
Volume lesion evaluation
Time Frame: 3 months
|
The volume of endometriosis nodule will be evaluated on MRI, before treatment and at 3 months after treatment. (blinded evaluation of the treatment groups). The volume variation observed in the HIFU group will be compared with those observed in the Sham Intervention group. |
3 months
|
Post treatment medication rate
Time Frame: 10 days
|
The level of post-treatment medication during the first 10 days will be collected in the patient diary.
The level of post-treatment medication in HIFU group will be compared to those in the sham intervention group.
|
10 days
|
Post treatment pain rate
Time Frame: 10 days
|
The level of pain will be evaluated by daily self-evaluation by the patients;rom 0 (best situation) to 10 (worst situation), and collected on the daily diary during the first 10 days post-intervention.
The pain level in HIFU group will be compared to the sham intervention group.
|
10 days
|
Overall recovery time evaluation
Time Frame: 3 months
|
The overall recovery time will be evaluated by the patients on the patient diary. The overall recovery time observed in the HIFU group will be compared to those observed in the Sham intervention group. |
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gil Dubernard, Pr, EDAP TMS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIFU/F/21.12
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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