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

NCT04494568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Endometriosis, Rectum

Interventions

DEVICE

HIFU treatment

HIFU Treatment of rectal endometriosis

Sponsors & Collaborators

  • EDAP TMS S.A.

    lead INDUSTRY

Principal Investigators

  • Gil DUBERNARD, Pr · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2022-11-01
Completion
2022-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04494568 on ClinicalTrials.gov