Spots Global Cancer Trial Database for Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

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Trial Identification

Brief Title: Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Official Title: One-arm, Multi-center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy

Study ID: NCT00462124

Conditions

Prostate Cancer

Interventions

Absorbable perirectal spacer

Study Description

Brief Summary: Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events. Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.

Detailed Description: Primary Endpoint Parameters The safety endpoint is incidence of complications related to BioProtect balloon implant and 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 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.