Prostate Mechanical Imager (PMI) Clinical Bridging Study
Completed
Conditions studied: Prostatic Neoplasms, Prostatic Hyperplasia
In brief
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, aimed at providing composite elasticity images of the prostate.
Key facts
- Study ID
- NCT00822952
- Run by
- Artann Laboratories
- People needed
- 71
- Starts
- 2008-10-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2014-03-31
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Minnesota/VA Medical Center — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Robert Wood Johnson Medical Center — New Brunswick, New Jersey, United States
- AccuMed Research Associates — Garden City, New York, United States
- Urology Associates of Lancaster — Lancaster, Pennsylvania, United States
Full record on ClinicalTrials.gov
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