Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
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|ClinicalTrials.gov Identifier: NCT00462124|
Recruitment Status : Unknown
Verified June 2009 by BioProtect.
Recruitment status was: Recruiting
First Posted : April 18, 2007
Last Update Posted : June 12, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: BioProtect biodegradable balloon implant Device: Ballon implantation||Phase 1|
Primary Endpoint Parameters
The safety endpoint is incidence of complications related to BioProtect balloon implant and 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
To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of:
- Increased distance between anterior rectal wall and prostate post implantation as showed by CT until last radiation treatment.
- 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
- Balloon non-displacement during treatment phase as shown by CT.
- Balloon remaining inflated during treatment phase as shown by CT.
- Operator satisfaction from BioProtect balloon implantation procedure.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2007|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||February 2010|
Device: BioProtect biodegradable balloon implant
- The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure [ Time Frame: 6 months ]
- Efficacy will be measured in terms of: [ Time Frame: 6 months ]
- Increased distance between anterior rectal wall [ Time Frame: 6 months ]
- Noticeable reduction of isodose level to the rectum [ Time Frame: 6 months ]
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): NCT00462124
|Contact: Yossi Muncher, Dr.||firstname.lastname@example.org|
|Contact: Shaul Shohatemail@example.com|
|Ichilov Medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Eli Gez, Dr. 972-3-6973914 firstname.lastname@example.org|
|Contact: Rami Ben Yosef, Prof. 972-3-6974833|
|Principal Investigator: Rami Ben-Yossef, Dr.|
|Study Director:||Yossi Muncher, Dr.||BioProtect|