Status:
ACTIVE_NOT_RECRUITING
Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System
Lead Sponsor:
BioProtect
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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 impl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05354440
Start Date
January 1 2022
End Date
January 1 2026
Last Update
September 19 2025
Active Locations (6)
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1
St Luke's Radiation Oncology
Dublin, Ireland
2
Assuta Ashdod medical center
Ashdod, Israel
3
Rabin Medical Center
Petah Tikva, Israel
4
Maastricht radiation oncology
Maastricht, Netherlands