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Completed

NCT Number: NCT03613298

Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.

Deep invasive endometriosis (DIE) includes lesions of the rectosigmoid. Theses lesions are 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 trial is to evaluate the ability of the Focal One® HIFU device to detect and target posterior DIE lesions with intestinal involvement. The secondary objectives are to perform a HIFU lesion, to evaluate morphological modifications of the nodule in post-therapeutic imaging scans, to assess evolution of gynecological symptoms, intestinal symptoms, and patients' quality of life after treatment by HIFU and to collect safety data.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

About this study

20 Subjects with deep invasive endometriosis (DIE) will receive the HIFU treatment with Focal One® device.

Subjects harboring an isolated recto-sigmoid DIE lesion with a persistence of symptoms despite hormonal treatment will be installed on the Focal One® device to:

  • Evaluate its ability to locate and assess the volume of the endometriosic lesion
  • Treat the targeted lesion by HIFU energy application. Real-time guided ultrasonography will be used to determine the location of the endometriosic nodule. Succession of HIFU exposure will be then used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae to prevent risk of fistulae.

Patients will fill-out questionnaires on gynecological and intestinal symptoms and on quality of life before treatment and at 1 and 6 months after HIFU procedure. Imaging follow-up scans will be organized at 1 and 6 months and by a pelvic MRI scan at 3/6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 25 years
  • Isolated recto-sigmoid DIE lesion, with no other endometriosis location on imaging examination (intestinal, urinary or ovarian), the persistence of symptoms despite hormonal treatment and therefore consideration for surgical management.
  • Localization of endometriosic lesion described by US, confirmed by MRI
  • Negative urinary pregnancy test and No intention to get pregnant during the following 6 months
  • Affiliated to the French Social Security System

Exclusion criteria

  • Hormonal treatment of endometriosis by Luteinizing Hormone Releasing Hormone agonist (LHRH analogs) of less than 3 months
  • Breastfeeding female
  • Uro-genital infection in progress (the infection has to be treated before HIFU treatment)
  • Anatomical abnormality of the rectum
  • Anterior surgery at the level of the anus or rectum
  • Presence of an implant (stent, catheter, contraceptive implant) located less than 1 cm from the treatment area.
  • History of intestinal inflammatory pathology
  • Allergy to latex
  • Female with a medical contraindication on MRI
  • Female with a medical contraindication to Sonovue® injection
  • Female not able to understand the objectives of the study
  • Legal person protected by law

Treatment and study plan

HIFU (Focal One®)

Device

Endometriosic lesion localization and HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using sonography, pelvic MRI and a transrectal sonography data. Once the pre-defined lesion will be located with Focal One device, succession of HIFU exposure will then be used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae.

Other names: High-Intensity Focused Ultrasounds

Primary outcomes

  1. Targeting of the endometriosic lesion

    Time frame: Day 1

    The main criterion of evaluation will lie on the targeting of the Endometriosic lesion with the Focal One® probe.

    Measure of the volume of the Endometriosic lesion to treat: targeted volume (estimation from the measures of the length, the height and the width of the nodule).

Secondary outcomes

  1. Anatomical position of the Focal One probe

    Time frame: Day 1

    The objective is to evaluate the position of the probe within the rectum before HIFU treatment.

  2. Effect of HIFU treatment on endometriosic lesion

    Time frame: Day 1

    Ratio calculation between targeted volume and treated volume and Evaluation of HIFU on symptomatology

  3. Safety of the procedure: assessment of complications during the procedure attributable to the technique

    Time frame: Day 1

    Complications during HIFU treatment attributable to the HIFU energy deposit or the Focal One are described here.

  4. Assessment of Adverse Events during the 6 months follow-up attributable to the technique

    Time frame: 6 months

    Complications post HIFU treatment.

  5. Medical Outcome assessment (Study Short Form-36)

    Time frame: 6 months

    self-administrated questionnaire: French version of the 36-item Short Form Survey (SF-36)

  6. endometriosis health profile assessment

    Time frame: 6 months

    self-administrated questionnaire: endometriosis health profile (EHP-5)

  7. Urinary symptom profile assessment

    Time frame: 6 months

    self-administrated questionnaire: urinary symptom profile (USP)

  8. Sexual function assessment

    Time frame: 6 months

    self-administrated questionnaire: Female Sexual Function Index (FSFI)

  9. Constipation assessment

    Time frame: 6 months

    self-administrated questionnaire: Knowles-Eccersley-Scott-Symptom Questionnaire (KESS score)

  10. Anal continence assessment

    Time frame: 6 months

    self-administrated questionnaire: Wexner score of anal continence

Sponsors and collaborators

Lead sponsor

EDAP TMS S.A.

Industry

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) Lesions With Intestinal Involvement

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Jul 31, 2019

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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