Last updated on July 2020

ProSpace Balloon System Pivotal Study BP-007

Brief description of study

The ProSpace 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 the ProSpace System to reduce the radiation dose delivered to the anterior rectum. ProSpace is a balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Detailed Study Description

This study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the ProSpace Balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (IMRT).

Clinical Study Identifier: NCT03400150

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Chesapeake Urology Research Associates

Owings Mills, MD United States
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Recruitment Status: Open

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