Clinical trial · Observational
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
NCT05354440CI-TRIAL-00095453CLP-10441active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Long Term Rectal And Urinary Toxicity and Quality of Life
- timeFrame
- 48 months
- description
- Long-term safety as assessed by incidence of urinary and bowel toxicities.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.