BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Public ClinicalTrials.gov record NCT03400150. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CLINICAL PROTOCOL for the INVESTIGATION Of the BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03400150
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2, 2018
- Primary completion
- Dec 9, 2021
- Completion
- Dec 9, 2021
- Last update posted
- Feb 17, 2025
2018 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Western Radiation Oncology | Apple Valley | California | 95008 | — |
| KSK Medical Center | Irvine | California | 92618 | — |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | — |
| Rush University Cancer Center | Chicago | Illinois | 60612 | — |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | — |
| Chesapeake Urology Research Associates | Owings Mills | Maryland | 21117 | — |
| Urology Nevada | Reno | Nevada | 89521 | — |
| Advanced Radiation Center of New York | Lake Success | New York | 11042 | — |
| New York University Langone Health | New York | New York | 10016 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03400150, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 17, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03400150 live on ClinicalTrials.gov.