Clinical trial NCT05755958: Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms.
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Rectal Endometriosis
HIFU
FocalOne
High Intensity Focused Ultrasound
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Comparison of the evolution in the level of acute pelvic pain compared to the sham intervention group.
timeFrame: 3 months
Secondary outcomes:
measure: Adverse Events occurrence and comparison between the two groups
timeFrame: 3 months
measure: Symptoms evolution evaluation
timeFrame: 1 and 3 months
measure: Evaluation of anal continence
timeFrame: 1 and 3 months
measure: Evaluation of constipation
timeFrame: 1 and 3 months
measure: Evaluation of urinary symptoms
timeFrame: 1 and 3 months
measure: Evaluation of sexual fonction
timeFrame: 1 and 3 months
measure: Quality of life evoluation
timeFrame: 1 and 3 months
measure: Volume lesion evaluation
timeFrame: 3 months
measure: Post treatment medication rate
timeFrame: 10 days
measure: Post treatment pain rate
timeFrame: 10 days
measure: Overall recovery time evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Hopital Privé de Provence
city: Angers
country: France
facility: CHU de Angers
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Clermont-Ferrand
country: France
facility: Chu Estaing
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital du Kremlin Bicetre
city: Lille
country: France
facility: Hôpital privé Le Bois
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Paris
country: France
facility: Hôpital COCHIN
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: EDAP TMS
name: Gil Dubernard, Pr
role: PRINCIPAL_INVESTIGATOR
References: