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Active, Not Recruiting

NCT Number: NCT05354440

Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

St Luke's Radiation Oncology, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

BioProtect

Industry

Registry information

Official study title

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

Acronym: CLP-10441

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2022
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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