Clinical trial NCT04494568: Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
Official title: Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis, Rectum
Keywords: rectal endometriosis, HIFU
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2020-07-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: INTERVENTIONAL, PROSPECTIVE, MULTICENTRIC, NON-RANDOMIZED AND NON-CONROLLED STUDY
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.

The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.


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

Primary outcomes:
measure: Evaluate the tolerance of rectal endometriosis treatment with HIFU
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the gynecological symptoms evolution of patients after HIFU treatment
timeFrame: at 1 month, 3 months and 6 months post-intervention
measure: Evaluation of the of quality of life evolution of patients after HIFU treatment
timeFrame: at 1 month, 3 months and 6 months post-intervention,
measure: Evaluation of the evolution of the nodule's volume
timeFrame: at 6 months
measure: Evaluation of the post-intervention analgesic treatment
timeFrame: during the fisrt 10 days post treatment.
measure: Evaluation of the digestive symptoms evolution of patients after HIFU treatment
timeFrame: at 1 month, 3 months and 6 months post-intervention
measure: Evaluation of the digestive symptoms evolution of patients after HIFU treatment
timeFrame: at 1 month, 3 months and 6 months post-intervention
measure: Evaluation of the sexual symptoms evolution of patients after HIFU treatment
timeFrame: at 1 month, 3 months and 6 months post-intervention
measure: Evaluation of the urinary symptoms evolution of patients after HIFU treatment
timeFrame: at 1 month, 3 months and 6 months post-intervention
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU de Angers
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital BICETRE
city: Lille
country: France
facility: Clinique de Gynécologie
city: Lyon
country: France
facility: Hopital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Gil DUBERNARD, Pr
role: PRINCIPAL_INVESTIGATOR
References: