Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
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|ClinicalTrials.gov Identifier: NCT00918229|
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : February 5, 2018
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 radiation therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting adverse events.
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: balloon implant Procedure: Balloon implantation||Not Applicable|
Primary Endpoint Parameters
The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon implant and/or implantation procedure:
- 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.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||One-arm, Multi-center, International Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
implantation of an absorbable perirectal spacer balloon
Device: balloon implant
Absorbable perirectal spacer implantation
Procedure: Balloon implantation
Implantation of the balloon between the prostate and the anterior rectal wall
- Safety - Class II adverse events [ Time Frame: 6 months ]incidence of complications related to BioProtect balloon implant and implantation procedure
- Dosage received by the rectal wall [ Time Frame: 6 months ]measured in terms of reduction in isodose to anterior wall
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918229
|United States, Virginia|
|Virginia Commonwealth University School of Medicine, Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0058|
|Study Director:||Yossi Muncher, Dr.||BioProtect|