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Completed

NCT Number: NCT04494568

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

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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIFU treatment

Device

HIFU Treatment of rectal endometriosis

Primary outcomes

  1. Evaluate the tolerance of rectal endometriosis treatment with HIFU

    Time frame: 6 months

    The tolerance of the treatment will be evaluated by the analysis of adverse events occurrence at 6 months post-HIFU treatment

Secondary outcomes

  1. Evaluation of the gynecological symptoms evolution of patients after HIFU treatment

    Time frame: at 1 month, 3 months and 6 months post-intervention

    EVA symptom Questionnaires

  2. Evaluation of the of quality of life evolution of patients after HIFU treatment

    Time frame: at 1 month, 3 months and 6 months post-intervention,

    Quality of life questionnaire : MOS- SF-36

  3. Evaluation of the evolution of the nodule's volume

    Time frame: at 6 months

    The pre- and post-treatment comparison of the volume of the endometriodsis nodule measurement.

  4. Evaluation of the post-intervention analgesic treatment

    Time frame: during the fisrt 10 days post treatment.

    The level of medication during the fisrt 10 days post treatment will be studied by analysing the data collected in patient book.

  5. Evaluation of the digestive symptoms evolution of patients after HIFU treatment

    Time frame: at 1 month, 3 months and 6 months post-intervention

    Wexner

  6. Evaluation of the digestive symptoms evolution of patients after HIFU treatment

    Time frame: at 1 month, 3 months and 6 months post-intervention

    Kess questionnaires

  7. Evaluation of the sexual symptoms evolution of patients after HIFU treatment

    Time frame: at 1 month, 3 months and 6 months post-intervention

    SFSI questionnaire

  8. Evaluation of the urinary symptoms evolution of patients after HIFU treatment

    Time frame: at 1 month, 3 months and 6 months post-intervention

    USP questionnaire

Sponsors and collaborators

Lead sponsor

EDAP TMS S.A.

Industry

Registry information

Acronym: ENDO-HIFU-R1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2020
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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