Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

N/AActive Not RecruitingNCT05354440

BioProtect80 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Long Term Rectal And Urinary Toxicity and Quality of Life

Long-term safety as assessed by incidence of urinary and bowel toxicities.

Time frame: 48 months

Data from ClinicalTrials.gov

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