The clinical trial evaluation of the efficacy of HIFU Treatment on Rectal Endometriosis Symptoms (ENDO-HIFU-R2)

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The research company EDAP TMS S.A is conducting the clinical trial Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms (ENDO-HIFU-R2).

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.

It is planned to include 60 participants.

Actual study start date is February 3, 2023. The researchers expect to complete the study by February 1, 2024.

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.

The study will take place in several research sites in the following locations: Aix-en-Provence, France; Angers, France; Bordeaux, France; Clermont-Ferrand, France; Le Kremlin-Bicêtre, France; Lille, France; Lyon, France; Paris, France; Strasbourg, France. For more details please visit: https://ichgcp.net/clinical-trials-registry/NCT05755958

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