SpaceIT Hydrogel System for Perirectal Spacing

NARecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

October 30, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Prostate Cancer
Interventions
DEVICE

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."

DEVICE

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.

Trial Locations (22)

10016

RECRUITING

Integrated Medical Professionals, New York

RECRUITING

Perlmutter Cancer Center - NYU Langone, New York

10065

RECRUITING

Memorial Sloan Kettering, New York

10075

RECRUITING

Northwell Health, New York

19004

RECRUITING

MidLantic Urology, Bala-Cynwyd

19104

RECRUITING

Perelman Center for Advanced Medicine, Philadelphia

29650

RECRUITING

Gibbs Cancer Center and Research Institute, Greer

30308

RECRUITING

Emory University Hospital, Atlanta

32806

RECRUITING

Orlando Health Cancer Institute, Orlando

33176

RECRUITING

Baptist Hospital of Miami, Miami

60026

RECRUITING

UroPartners, Glenview

60415

RECRUITING

Associated Urological Specialists, Chicago Ridge

62701

RECRUITING

Springfield Clinic, LLC, Springfield

66160

RECRUITING

University of Kansas Hospital, Kansas City

75390

RECRUITING

University of Texas, Southwestern Medical Center, Dallas

77027

RECRUITING

Houston Metro Urology, Houston

78705

RECRUITING

Midtown Urology Associates, Austin

79912

RECRUITING

Rio Grande Urology, El Paso

90095

RECRUITING

Ronald Reagan UCLA Medical Center, Los Angeles

98034

RECRUITING

Evergreen Hospital Medical Center, Kirkland

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre-Hospital, Toronto

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre, Toronto

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY