SciBase International Melanoma Pivotal Study

Not Applicable

Completed

• Conditions: Malignant Melanoma
• Interventions: Device: SciBase III Electrical Impedance Spectrometer

• Registration Number: NCT01077050
• Lead Sponsor: SciBase AB

Brief Summary

The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).

The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Study Start: 2010-04
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Results First Submitted: 2013-06-12
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Results First Posted: 2013-12-30
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1951

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects were excluded from the study if they fulfilled any of the following criteria:

• Skin surface not measurable, e.g. lesion on a stalk
• Skin surface not accessible, e.g. inside ears, under nails
• Lesion located on acral skin, e.g. sole or palms.
• Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions.
• Lesion on hair-covered areas, e.g. scalp, beards, moustaches or whiskers.
• Lesion located on genitalia.
• Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized.
• Lesion located on mucosal surfaces.
• Skin is not intact (measurement area) e.g. bleeding or with clinical noticeable ulceration.
• Lesion with foreign matter, e.g. tattoo, splinter
• Lesion and/or reference located on acute sunburn.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SciBase III	SciBase III Electrical Impedance Spectrometer	Subjects with suspected malignant melanoma or lesions designated for total excision were included into the study. To ensure no selection bias, all eligible lesions from a subject were included into the study. All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.

Primary Outcome Measures

Name	Time	Method
SciBase Sensitivity and Specificity	Post data lock	This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma; 2. Sensitivity - (1-Specificity) \> 0.00; Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	Post data lock	Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.; Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia); Negative Reference Diagnosis: All other skin lesions.

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden