Back to resultsInternational Melanoma Algorithm Training Study - IMATS
Primary Purpose
Malignant Melanoma
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SciBase III Electrical Impedance Spectrometer
Sponsored by
About this trial
This is an interventional diagnostic trial for Malignant Melanoma
Eligibility Criteria
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.
Sites / Locations
- Sahlgrenska University Hospital, Dpt. of Dermatology
Outcomes
Primary Outcome Measures
Outcome measure not applicable. This is an algorithm training study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00966173
Brief Title
International Melanoma Algorithm Training Study - IMATS
Official Title
An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SciBase AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SciBase III Electrical Impedance Spectrometer
Intervention Description
Following enrollment, patients will undergo measurements with SciBase III Electrical Impedance Spectrometer. Electrical impedance of the skin will be measured with a microinvasive spiked probe.
Primary Outcome Measure Information:
Title
Outcome measure not applicable. This is an algorithm training study.
Time Frame
Q1 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sahlgrenska University Hospital, Dpt. of Dermatology
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
International Melanoma Algorithm Training Study - IMATS
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