Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358111
Status:
TERMINATED
Last Update Posted:
2014-05-13
First Post:
2006-07-27
Brief Title:
Study of LUMA Cervical Imaging System as Adjunct to Colposcopy
Sponsor:
SpectraScience
Organization:
SpectraScience
Study Overview
Official Title:
A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PMA withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a post-approval multi-center single-arm study n950 designed to address the relationship of the LUMA device performance to patient age patient human papillomavirus HPV status and colposcopist experience
Detailed Description:
None
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