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Clinical Trials in Israel / NCT05354440
Active, not recruiting Observational

Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

NCT05354440 · tracked via the Priya Life Science Israel tracker
Sponsor
BioProtect
Phase
Observational
Started
2022-01-01
Last updated
2025-09-19

Condition(s) studied

Prostate Cancer

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 sites (6)

FacilityCityRegionStatus
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

Other trials for the same condition

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer Recruiting
ExosomeDx in MRI-negative Men With High PSA Starting soon
PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy Starting soon
INTREPId (INTermediate Risk Erection PreservatIon Trial) Active, not recruiting
Clinical Trial of Approaches to Prostate Cancer Surgery Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05354440 on ClinicalTrials.gov ↗ ← All trials in Israel