International Melanoma Algorithm Training Study - IMATS

SciBase

Status: Completed

Conditions: Malignant Melanoma

Treatments: Device: SciBase III Electrical Impedance Spectrometer

Study type: Interventional

Funder types: Other

Identifiers

NCT00966173

6001

Details and patient eligibility

About

This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study [IMATS]). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women of any ethnic group
• Lesion located on normal healthy skin
• Maximum number of eight lesions per patient
• etc.

Exclusion criteria

• Lesion under finger and toe nails
• Lesion located on eczema, psoriasis areas or similar
• Lesion located on scars
• etc.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)