Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System (CLP-10441)

BioProtect

Status: Active, not recruiting

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT05354440

CLP-10441

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.