Cancer types
  • Urology
Title of study
Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System
Version Number
Approval Date 
CLP-10441, 25 November 2021
Short Title
ProSpace Longterm
Study site
Principle Investigator
Dafna Carmi-Yinon
Investigator Maastro
Dr. Evert van Limbergen
Sponsor
BioProtect Ltd.
Trial registry
Objectives 

The main objective of this PMCF study is to assess late toxicity and quality of life in subjects who participated in BP-007 clinical study. The study evaluates the late urinary and bowel toxicity and quality of life in subjects who were implanted with the ProSpace Balloon Spacer compared to late urinary and bowel toxicity and quality of life in subjects who were marked only with fiducial markers and/or radio beacons.

Primary Endpoint 

Late toxicity: the late urinary and bowel toxicity

Secondary Endpoints 

Quality of life

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