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

EDAP TMS

Status: Active, not recruiting

Conditions: Endometriosis

Treatments: Device: HIFU treatment in rectal Endometriosis; Device: SHAM HIFU procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT05755958

HIFU/F/21.12

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

HIFU SHAM

Sham Comparator group

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.

Treatment:

Device: SHAM HIFU procedure

HIFU TREATMENT

Active Comparator group

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.

Treatment:

Device: HIFU treatment in rectal Endometriosis