Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
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 radiation therapy (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.
Description
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.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Prostate Cancer
Intervention
BioProtect biodegradable balloon implant, Balloon implantation
Location
Virginia Commonwealth University School of Medicine, Massey Cancer Center
Richmond
Virginia
United States
23298-0058
Status
Not yet recruiting
Source
BioProtect
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00918229
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Intra-aortic Balloon Pumping
Counterpulsation in which a pumping unit synchronized with the patient's electrocardiogram rapidly fills a balloon in the aorta with helium or carbon dioxide in early diastole and evacuates the balloon at the onset of systole. As the balloon inflates, it raises aortic diastolic pressure, and as it deflates, it lowers aortic systolic pressure. The result is a decrease in left ventricular work and increased myocardial and peripheral perfusion.
Angioplasty, Balloon, Laser-assisted
Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.
Balloon Occlusion
Use of a balloon catheter to block the flow of blood through an artery or vein.
Angioplasty, Balloon
Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.
Angioplasty, Balloon, Coronary
Dilation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.
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