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SciBase International Melanoma Pivotal Study

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SciBase III Electrical Impedance Spectrometer
Sponsored by
SciBase AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

For inclusion in the study, all subjects had to fulfill all of the following criteria:

  • Men or women of any ethnic group aged ≥18 years
  • Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise.
  • Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter
  • In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once.
  • The subject is willing and able to read, understand and sign the study specific informed consent form.

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.

Sites / Locations

  • University of Arizona
  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SciBase III

Arm Description

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.

Outcomes

Primary Outcome Measures

SciBase Sensitivity and Specificity
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: Sensitivity ≥ 0.90 to detect Melanoma 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

Sensitivity and Specificity
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.

Full Information

First Posted
February 25, 2010
Last Updated
November 8, 2013
Sponsor
SciBase AB
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1. Study Identification

Unique Protocol Identification Number
NCT01077050
Brief Title
SciBase International Melanoma Pivotal Study
Official Title
SciBase International Melanoma Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciBase AB

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
1951 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SciBase III
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SciBase III Electrical Impedance Spectrometer
Intervention Description
SciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment.
Primary Outcome Measure Information:
Title
SciBase Sensitivity and Specificity
Description
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: Sensitivity ≥ 0.90 to detect Melanoma 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.
Time Frame
Post data lock
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity
Description
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.
Time Frame
Post data lock

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria For inclusion in the study, all subjects had to fulfill all of the following criteria: Men or women of any ethnic group aged ≥18 years Primary lesions (i.e., not metastases or recurrent lesions) that the physicians choose to excise. Lesion ≥ 2 mm in diameter and ≤ 20 mm in diameter In subjects with multiple skin lesions, all lesions destined for excision must be identified for purposes of study participation. Note: a subject may only be entered into the study once. The subject is willing and able to read, understand and sign the study specific informed consent form. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik H Birgersson, PhD
Organizational Affiliation
SciBase and Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
12877688
Citation
Aberg P, Nicander I, Holmgren U, Geladi P, Ollmar S. Assessment of skin lesions and skin cancer using simple electrical impedance indices. Skin Res Technol. 2003 Aug;9(3):257-61. doi: 10.1034/j.1600-0846.2003.00017.x.
Results Reference
background
PubMed Identifier
15605856
Citation
Aberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. Skin cancer identification using multifrequency electrical impedance--a potential screening tool. IEEE Trans Biomed Eng. 2004 Dec;51(12):2097-102. doi: 10.1109/TBME.2004.836523.
Results Reference
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SciBase International Melanoma Pivotal Study

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