Endometriosis Clinical Trial
Official title:
Evaluation of the Location and the Treatment by High-intensity Focused Ultrasounds (HIFU) of Posterior Deep Infiltrating Endometriosis (DIE) 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.
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.
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