Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

Endometriosis, Rectum Clinical Trial

— ENDO-HIFU-R1  

Official title:

Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494568
• Other study ID #: HIFU-F-20.01
• Status: Completed
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: EDAP TMS S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis, Rectum

Intervention

Device:
• HIFU treatment
HIFU Treatment of rectal endometriosis

Locations

Country	Name	City	State
France	CHU de Angers	Angers
France	Clinique Tivoli-Ducos	Bordeaux
France	Hôpital BICETRE	Le Kremlin-Bicêtre
France	Clinique de Gynécologie	Lille
France	Hopital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
EDAP TMS S.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the tolerance of rectal endometriosis treatment with HIFU	The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment	6 months
Secondary	Evaluation of the gynecological symptoms evolution of patients after HIFU treatment	EVA symptom Questionnaires	at 1 month, 3 months and 6 months post-intervention
Secondary	Evaluation of the of quality of life evolution of patients after HIFU treatment	Quality of life questionnaire : MOS- SF-36	at 1 month, 3 months and 6 months post-intervention,
Secondary	Evaluation of the evolution of the nodule's volume	The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.	at 6 months
Secondary	Evaluation of the post-intervention analgesic treatment	The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.	during the fisrt 10 days post treatment.
Secondary	Evaluation of the digestive symptoms evolution of patients after HIFU treatment	Wexner	at 1 month, 3 months and 6 months post-intervention
Secondary	Evaluation of the digestive symptoms evolution of patients after HIFU treatment	Kess questionnaires	at 1 month, 3 months and 6 months post-intervention
Secondary	Evaluation of the sexual symptoms evolution of patients after HIFU treatment	SFSI questionnaire	at 1 month, 3 months and 6 months post-intervention
Secondary	Evaluation of the urinary symptoms evolution of patients after HIFU treatment	USP questionnaire	at 1 month, 3 months and 6 months post-intervention