One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Primary Endpoint Parameters
The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard
balloon implant and/or implantation procedure:
1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure.
Serious adverse event are defined as adverse requiring operation and/or associated with
prolongation of hospital stay. Serious Adverse Events will be documented in Serious
Adverse Event Form.
2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse
Events will be documented in Adverse Event Form.
3. Subjective discomfort related to the balloon and implantation procedure will be
assessed by pain analogue scale.
Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50
in at least 75% of the subjects after balloon implantation as compared to the doses at V50
before the balloon implantation. This will be measured by routine Dose Volume Histogram
(DVH) per local hospital practice and according to the instruction regarding anatomical
landmarks delineated in this protocol.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure
Yossi Muncher, Dr.
United States: Food and Drug Administration
|Virginia Commonwealth University School of Medicine, Massey Cancer Center||Richmond, Virginia 23298-0058|