Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

NAActive, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

May 21, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Prostate Cancer
Interventions
DEVICE

BioProtect Balloon Implant™ System

The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time

Trial Locations (1)

11042

Advanced Radiation Centers of New York, New Hyde Park

All Listed Sponsors
lead

Advanced Radiation Centers of New York

OTHER

NCT06599476 - Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy | Biotech Hunter | Biotech Hunter