Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System (CLP-10441)

September 15, 2025 updated by: BioProtect

Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System

Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of IMRT following implantation of the BioProtect Balloon Implant System.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • St Luke's Radiation Oncology
  • Israel
      • Ashdod, Israel
        • Assuta Ashdod Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht Radiation Oncology
  • Poland
      • Warsaw, Poland
        • Institute of Maria Skłodowska - Curie
  • Portugal
      • Porto, Portugal
        • Cuf Porto institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who previously participated in the BP-007 clinical study

Description

Inclusion Criteria:

  1. Subject has previously participated in the BP-007 clinical study and completed their IMRT treatment.
  2. Subject agrees to complete all required follow-up visits.
  3. Subject provides written Informed Consent prior to any study related procedure

Exclusion Criteria:

  1. Subject who completed 48 months of follow-up in the BP-007 study.
  2. Subjects who are receiving at the time of the study, any other investigational agents/ devices.
  3. Subjects unwilling and/or unable to comply with the provisions of the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long Term Rectal And Urinary Toxicity and Quality of Life
Time Frame: 48 months
Long-term safety as assessed by incidence of urinary and bowel toxicities.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioProtect

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-10441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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