Ignite Creation Date:
2024-05-05 @ 9:09 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00822952
Status:
COMPLETED
Last Update Posted:
2014-03-31
First Post:
2009-01-14
Brief Title:
Prostate Mechanical Imager PMI Clinical Bridging Study
Sponsor:
Artann Laboratories
Organization:
Artann Laboratories
Study Overview
Official Title:
Prostate Mechanical Imager PMI Clinical Bridging Study
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMI
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
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 dimensions of the prostate by measuring mechanical stress patterns on the gland surface with pressure sensor arrays Temporal and spatial changes in the stress pattern provide information on the hardness of the prostate Projected patient sample size for the study is 40 men over the age of 21 Patients will be selected for the study if both of the following criteria are met 1 abnormal DRE findings and 2 patients who are scheduled for a TRUS-guided prostate biopsy and or radical prostatectomy due to an abnormal DRE andor increased PSA andor other clinical indications
The study is designed to assess the imaging capability of the PMI in three clinical sites performed by four physicians Each clinical investigator will perform PMI examination on 10 respective patients with DRE detected abnormality Pathology data will be collected from TRUS-guided biopsy or radical prostatectomy and will be used as reference data in case there is a discrepancy between the DRE findings and PMI images Study Hypothesis Proportion of patients with PMI reconstructed image is anticipated to be consistent with the 84 imaging capability demonstrated in the previous clinical study conducted with the prior version of the PMI device
The study is designed to assess the imaging capability of the PMI in three clinical sites performed by four physicians Each clinical investigator will perform PMI examination on 10 respective patients with DRE detected abnormality Pathology data will be collected from TRUS-guided biopsy or radical prostatectomy and will be used as reference data in case there is a discrepancy between the DRE findings and PMI images Study Hypothesis Proportion of patients with PMI reconstructed image is anticipated to be consistent with the 84 imaging capability demonstrated in the previous clinical study conducted with the prior version of the PMI device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44CA082620 | NIH | None | httpsreporternihgovquickSearch5R44CA082620 |