Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

December 31, 2010

Conditions
Uterine FibroidsUterine Leiomyomata
Interventions
DEVICE

Philips MR guided HIFU system

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis

Trial Locations (2)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

77030

St. Luke's Episcopal Hospital, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Philips Healthcare

INDUSTRY