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

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 21, 2015

Primary Completion Date

May 31, 2019

Study Completion Date

May 31, 2019

Conditions
Endometriosis
Interventions
DEVICE

HIFU (Focal One®)

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.

Trial Locations (1)

69004

Hôpital de la Croix Rousse, Lyon

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

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

OTHER_GOV

lead

EDAP TMS S.A.

INDUSTRY