Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Uterine Fibroids
Interventions
DEVICE

MR-HIFU treatment

A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

DEVICE

Sham treatment

A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Trial Locations (9)

10467

Montefiore Medical Center, The Bronx

37232

Vanderbilt Medical Center, Nashville

48109

University of Michigan, Ann Arbor

60637

University of Chicago, Chicago

75235

University of Texas Southwestern Medical Center, Dallas

77030

St. Luke's Episcopal Hospital, Houston

97239

Oregon Science and Health University, Portland

Unknown

Sunnybrook Health Sciences Centre, Toronto

Samsung Medical Center, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Philips Healthcare

INDUSTRY