Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01692405
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2012-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Sponsor:
UC Care, Ltd.
Organization:
Study Overview
Official Title:
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Status:
COMPLETED
Status Verified Date:
2012-09
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:
None
Brief Summary:
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
1. Biopsy core length obtained (i.e. collecting all tissue fragments)
2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
3. Pathologist interpretability
4. Processing time
5. Prostate cancer detection.
1. Biopsy core length obtained (i.e. collecting all tissue fragments)
2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
3. Pathologist interpretability
4. Processing time
5. Prostate cancer detection.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: