Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434057
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2007-02-08
Brief Title:
Evaluation of Pigmented Skin Lesions With MelaFindR System
Sponsor:
MELA Sciences Inc
Organization:
MELA Sciences Inc
Study Overview
Official Title:
Evaluation of Pigmented Skin Lesions With MelaFindR System
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The purpose of this clinical trial is to demonstrate that MelaFind a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma is safe and effective MelaFind acquires digital images of the lesion with illumination in different spectral bands from visible to near infrared and automatically analyzes these images Diagnostic accuracy of MelaFind and that of study dermatologists will be evaluated The reference standard will be final interpretation of lesions by central dermatohistopathology
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