230
Participants
Start Date
October 30, 2024
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2028
SpaceIT Hydrogel System
"SpaceIT Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use.~SpaceIT has an iodinated PEG powder making it radiopaque."
Commercially available Boston Scientific Spacer
Boston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
RECRUITING
Integrated Medical Professionals, New York
RECRUITING
Perlmutter Cancer Center - NYU Langone, New York
RECRUITING
Memorial Sloan Kettering, New York
RECRUITING
Northwell Health, New York
RECRUITING
MidLantic Urology, Bala-Cynwyd
RECRUITING
Perelman Center for Advanced Medicine, Philadelphia
RECRUITING
Gibbs Cancer Center and Research Institute, Greer
RECRUITING
Emory University Hospital, Atlanta
RECRUITING
Orlando Health Cancer Institute, Orlando
RECRUITING
Baptist Hospital of Miami, Miami
RECRUITING
UroPartners, Glenview
RECRUITING
Associated Urological Specialists, Chicago Ridge
RECRUITING
Springfield Clinic, LLC, Springfield
RECRUITING
University of Kansas Hospital, Kansas City
RECRUITING
University of Texas, Southwestern Medical Center, Dallas
RECRUITING
Houston Metro Urology, Houston
RECRUITING
Midtown Urology Associates, Austin
RECRUITING
Rio Grande Urology, El Paso
RECRUITING
Ronald Reagan UCLA Medical Center, Los Angeles
RECRUITING
Evergreen Hospital Medical Center, Kirkland
RECRUITING
Sunnybrook Health Sciences Centre-Hospital, Toronto
RECRUITING
Princess Margaret Cancer Centre, Toronto
Lead Sponsor
Boston Scientific Corporation
INDUSTRY