SpaceOAR System Pivotal Study

PHASE3CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Prostate Cancer
Interventions
DEVICE

SpaceOAR System

Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.

Trial Locations (20)

11042

Advanced Radiation Centers of New York, Lake Success

13210

Associated Medical Professionals of NY, Syracuse

Upstate Medical University, Syracuse

14267

Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY, Erie, Niagara, and Chautauqua County

14642

University of Rochester, Rochester

21117

Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center), Owings Mills

21231

Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences, Baltimore

29577

21st Century Oncology, Myrtle Beach

30322

Emory University, Atlanta

33907

21st Century Oncology, Fort Myers

34202

Lakewood Ranch Oncology Center/21st Century Oncology, Bradenton

44106

University Hospitals Case Medical Center, Cleveland

80211

The Urology Center of Colorado, Denver

85013

Foundation for Cancer Research and Education, Phoenix

89521

Northern Nevada Radiation Oncology, Reno

95008

Urological Surgeons of Northern California, Campbell

95815

Radiological Associates of Sacramento, Sacramento

97477

Oregon Urology Institute, Springfield

98370

Peninsula Cancer Center, Poulsbo

07728

CentraState Medical Center, Freehold

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Augmenix, Inc.

INDUSTRY

lead

Boston Scientific Corporation

INDUSTRY

NCT01538628 - SpaceOAR System Pivotal Study | Biotech Hunter | Biotech Hunter