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Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Sponsor: Advanced Radiation Centers of New York
Summary
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement. The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer. Study visits: * Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1,3,and 6-months FU visits.
Official title: Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-05-21
Completion Date
2025-12
Last Updated
2025-05-22
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Advanced Radiation Centers of New York
New Hyde Park, New York, United States