SciBase International Melanoma Pivotal Study
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma
Both
Malignant Melanoma
Trial Information
SciBase International Melanoma Pivotal Study
Inclusion Criteria:
- Men or women of any ethnic group aged ≥18 years
- Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter
Exclusion Criteria:
- Skin surface not measurable, e.g. lesion on a stalk
- Lesion located on acral skin, e.g. sole or palms
- Lesion and/or reference located on acute sunburn
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
Device Sensitivity and Specificity
Outcome Description:
Consists of two co-endpoints aiming to show a Sensitivity (device) ≥ 0.90 to detect malignant melanoma and a Sensitivity - (1-Specificity) > 0.00
Outcome Time Frame:
One year
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
SIMPS
NCT ID:
NCT01077050
Start Date:
April 2010
Completion Date:
October 2011
Related Keywords:
- Malignant Melanoma
- Melanoma
Name | Location |
|---|---|
| University of Arizona | Tucson, Arizona 85724 |
