One-Arm, Multi-Center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Primary Endpoint Parameters
The safety endpoint is incidence of complications related to BioProtect balloon implant and
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
To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be
measured in terms of:
1. Increased distance between anterior rectal wall and prostate post implantation as
showed by CT until last radiation treatment.
2. Noticeable reduction of isodose level to the rectum post implantation as compared to
pre-implantation isodose to the rectum by XRT treatment planning software.
Other Measured Observations
1. Balloon non-displacement during treatment phase as shown by CT.
2. Balloon remaining inflated during treatment phase as shown by CT.
3. Operator satisfaction from BioProtect balloon implantation procedure.
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.
Israel: Ministry of Health