Prostate Mechanical Imager (PMI) Clinical Bridging Study

NCT00822952 | Completed

• 2 other identifiers: PMI-035R44CA082620
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 5

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, aimed at providing composite elasticity images of the prostate.

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Prostate Mechanical Imager provides reconstructed image of prostate

  1 Year

Secondary Outcomes (1)

• Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings

  1 Year

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult male patients between over the age of 21 presenting to the participating clinical sites for urologic examination with the DRE detected prostate abnormality and scheduled for a TRUS-guided prostate biopsy and/ or radical prostatectomy due to an abnormal DRE, and/or increased PSA, and/or other clinical indications will be considered for inclusion. All ethnic and racial groups will be included.

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,
• st, 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

Sponsors & Collaborators

• Artann Laboratories: lead
• National Cancer Institute (NCI): collaborator
• Rutgers, The State University of New Jersey: collaborator
• Mayo Clinic: collaborator
• University of Minnesota: collaborator

Study Sites (5)

University of Minnesota/VA Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Robert Wood Johnson Medical Center

New Brunswick, New Jersey, 08903, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Urology Associates of Lancaster

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (1)

• Weiss RE, Egorov V, Ayrapetyan S, Sarvazyan N, Sarvazyan A. Prostate mechanical imaging: a new method for prostate assessment. Urology. 2008 Mar;71(3):425-9. doi: 10.1016/j.urology.2007.11.021.

  PMID: 18342178 BACKGROUND

Related Links

• Artann Laboratories

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Armen Sarvazyan, Ph.D., D.Sc.

  Artann Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 31, 2014

Record last verified: 2014-03

Locations

US (5)