CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 222 enrolled
Drug / intervention
balloon +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03400150
NCT03400150N/ACompleted
CompareCT.gov

CLINICAL PROTOCOL for the INVESTIGATION Of the BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

BioProtect·interventional·Posted Jan 17, 2018·Updated Feb 18, 2025

In Brief

A clinical study evaluating balloon and Control for Prostate Cancer. Completed, enrolled 222 participants across 16 sites in 6 countries.

Detailed Summary

The BioProtect Balloon Implant™ 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 balloon to reduce the radiation dose delivered to the anterior rectum. The 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesIsrael, Netherlands, Poland, Portugal, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 17, 2018
Enrollment StartJan 3, 2018
Primary CompletionDec 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.5 years ago

Interventions

balloondevice

balloon implantation

Controlother

Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention