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SciBase International Melanoma Pivotal Study


N/A
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

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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 ArizonaTucson, Arizona  85724