Clinical trial · Observational
Prostate Mechanical Imager (PMI) Clinical Bridging Study
NCT00822952CI-TRIAL-00014133PMIcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prostate Mechanical Imager provides reconstructed image of prostate
- timeFrame
- 1 Year
Secondary outcomes (1)
- measure
- Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings
- timeFrame
- 1 Year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- BACKGROUNDWeiss 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