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BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007

NCT03400150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2025-02-18

Study results available
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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.

Conditions

Interventions

DEVICE

balloon

balloon implantation

OTHER

Control

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

Sponsors & Collaborators

  • BioProtect

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2021-12-10
Completion
2021-12-10
FDA Device
Yes

Countries

  • United States
  • Israel
  • Netherlands
  • Poland
  • Portugal
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400150 on ClinicalTrials.gov