Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT05354440
• Lead Sponsor: BioProtect

Brief Summary

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

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long Term Rectal And Urinary Toxicity and Quality of Life	48 months	Long-term safety as assessed by incidence of urinary and bowel toxicities.

Trial Locations

Locations (6)

St Luke's Radiation Oncology; 🇮🇪 Dublin, Ireland

Assuta Ashdod medical center; 🇮🇱 Ashdod, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Maastricht radiation oncology; 🇳🇱 Maastricht, Netherlands

Institute of Maria Skłodowska - Curie; 🇵🇱 Warsaw, Poland

Cuf Porto institution; 🇵🇹 Porto, Portugal