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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 80
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Assuta Ashdod medical center
🇮🇱Ashdod, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Maastricht radiation oncology
🇳🇱Maastricht, Netherlands
Institute of Maria Skłodowska - Curie
🇵🇱Warsaw, Poland
St Luke's Radiation Oncology
🇮🇪Dublin, Ireland
Cuf Porto institution
🇵🇹Porto, Portugal