Status:
COMPLETED
Prostate Mechanical Imager (PMI) Clinical Bridging Study
Lead Sponsor:
Artann Laboratories
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Conditions:
Prostatic Neoplasms
Prostatic Hyperplasia
Eligibility:
MALE
21+ years
Brief Summary
The purpose of this study is to evaluate an imaging capability Prostate Mechanical Imager (PMI), a PC-based device utilizing a transrectal probe with pressure sensor arrays and motion tracking system,...
Detailed Description
The clinical application of a Prostate Mechanical Imaging (PMI) technique for prostate assessment is examined in this study. PMI technology is based on the visualization of internal structures and dim...
Eligibility Criteria
Inclusion
- all racial and ethnic groups,
- males 21 years of age or older,
- able to withstand body positioning for the entire length of examination,
- presence of DRE detected abnormality,
- scheduled for TRUS-biopsy or surgical removal or prostate,
- able to comprehend, sign, and date the written informed consent form (ICF)
Exclusion
- previous pelvic surgery,
- significant hip and / vertebral arthritis,
- rectal Crohn's disease,
- locally disseminated cancer of pelvic structure,
- anal fissure, anal fistula, infected anal fistula,
- anal cancer,
- rectal cancer,
- 1st, 2nd or 3rd degree hemorrhoids,
- pelvic irradiation,
- dehydrated impacted stool,
- no vulnerable patients such as students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity will be included in the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00822952
Start Date
October 1 2008
End Date
September 1 2009
Last Update
March 31 2014
Active Locations (5)
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1
University of Minnesota/VA Medical Center
Minneapolis, Minnesota, United States, 55455
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States, 08903
4
AccuMed Research Associates
Garden City, New York, United States, 11530