Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03400150 · ClinicalTrials.gov registry record · NA
BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
A NA study, sponsored by BioProtect.
- Completed
- Registry status
- NA
- Development phase
- 222
- Enrollment target
NCT03400150: Completed NA study, sponsored by BioProtect.
NCT03400150 is a NA study that has completed, run by BioProtect. The registered enrollment target is 222 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400150, a NA study, has completed, sponsored by BioProtect.
- COMPLETED
- Registry status
- NA
- Development phase
- 222 participants
- Enrollment target
Study 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.
Primary Outcome
Non-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group
Interventions
- OTHER Control
- DEVICE balloon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2021-12-10 |
| Phase | NA |
What the finished NCT03400150 record still lists
NCT03400150 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT03400150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03400150 about?
NCT03400150 is a clinical study titled "BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007". 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 com...
What is the current status of trial NCT03400150?
This trial is currently completed. It is a NA study. The enrollment target is 222 participants. The study started on 2018-01-03. Estimated completion is 2021-12-10.
What interventions are being tested in trial NCT03400150?
The interventions under investigation include: Control (OTHER), balloon (DEVICE).
Who is sponsoring clinical trial NCT03400150?
This trial is sponsored by BioProtect, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03400150's enrollment target sits among peer trials
222 481st of 2000 higher than 1,520 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04939610 · 222 participants · Phase 1
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
- NCT05424783 · 222 participants
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
- NCT05568264 · 222 participants · NA
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
- NCT05605574 · 222 participants · NA
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI