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Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms. (ENDO-HIFU-R2)

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HIFU treatment in rectal Endometriosis
SHAM HIFU procedure
Sponsored by
EDAP TMS S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Rectal Endometriosis, HIFU, FocalOne, High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Privé de ProvenceRecruiting
  • CHU de AngersRecruiting
  • Clinique Tivoli-DucosRecruiting
  • Chu EstaingRecruiting
  • Hôpital du Kremlin BicetreRecruiting
  • Hôpital privé Le BoisRecruiting
  • Hopital de la Croix RousseRecruiting
  • Hôpital COCHINRecruiting
  • CHU StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

HIFU SHAM

HIFU TREATMENT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
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.

Secondary Outcome Measures

Adverse Events occurrence and comparison between the two groups
Occurrence of adverse events during the 3 months of post-intervention follow-up will be evaluated in each group.
Symptoms evolution evaluation
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.
Evaluation of anal continence
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.
Evaluation of constipation
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.
Evaluation of urinary symptoms
USP (Urinary Symptoms Profile) is a questionnaire that assesses urinary symptoms. It includes 13 questions grouped in 3 domains: Incontinence ranging from 0 to 9 Overactive bladder ranging from 0 to 21 Dysuria ranging from 0 to 9 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.
Evaluation of sexual fonction
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.
Quality of life evoluation
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.
Volume lesion evaluation
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.
Post treatment medication rate
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.
Post treatment pain rate
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.
Overall recovery time evaluation
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.

Full Information

First Posted
January 30, 2023
Last Updated
July 24, 2023
Sponsor
EDAP TMS S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05755958
Brief Title
Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.
Acronym
ENDO-HIFU-R2
Official Title
Doubled Blind Evaluation of the Efficacy of High Intensity Focused Ultrasound (HIFU) Treatment on Symptoms in Patients Treated for Rectal Endometriosis Compared to Sham.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

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
No

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Rectal Endometriosis, HIFU, FocalOne, High Intensity Focused Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFU SHAM
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
HIFU TREATMENT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HIFU treatment in rectal Endometriosis
Intervention Description
HIFU treatment of rectal endometriosis
Intervention Type
Device
Intervention Name(s)
SHAM HIFU procedure
Intervention Description
SHAM HIFU procedure
Primary Outcome Measure Information:
Title
Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Adverse Events occurrence and comparison between the two groups
Description
Occurrence of adverse events during the 3 months of post-intervention follow-up will be evaluated in each group.
Time Frame
3 months
Title
Symptoms evolution evaluation
Description
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.
Time Frame
1 and 3 months
Title
Evaluation of anal continence
Description
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.
Time Frame
1 and 3 months
Title
Evaluation of constipation
Description
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.
Time Frame
1 and 3 months
Title
Evaluation of urinary symptoms
Description
USP (Urinary Symptoms Profile) is a questionnaire that assesses urinary symptoms. It includes 13 questions grouped in 3 domains: Incontinence ranging from 0 to 9 Overactive bladder ranging from 0 to 21 Dysuria ranging from 0 to 9 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.
Time Frame
1 and 3 months
Title
Evaluation of sexual fonction
Description
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.
Time Frame
1 and 3 months
Title
Quality of life evoluation
Description
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.
Time Frame
1 and 3 months
Title
Volume lesion evaluation
Description
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.
Time Frame
3 months
Title
Post treatment medication rate
Description
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.
Time Frame
10 days
Title
Post treatment pain rate
Description
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.
Time Frame
10 days
Title
Overall recovery time evaluation
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire JOSSAN
Phone
+33472153175
Email
affaires-cliniques@edap-tms.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Dubernard, Pr
Organizational Affiliation
EDAP TMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Privé de Provence
City
Aix-en-Provence
ZIP/Postal Code
13080
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Philippe Estrade, Dr
Facility Name
CHU de Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Legendre, Dr
Facility Name
Clinique Tivoli-Ducos
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Dennis, Dr
Facility Name
Chu Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Canis, Pr
Facility Name
Hôpital du Kremlin Bicetre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine Capmas, Dr
Facility Name
Hôpital privé Le Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Collinet, Pr
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gil Dubernard, Pr
First Name & Middle Initial & Last Name & Degree
Charles-André Philip, dr
Facility Name
Hôpital COCHIN
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Marcellin, Dr
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Faller, Dr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.

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