Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioProtect
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System
