International Melanoma Algorithm Training Study - IMATS
An International, Multicenter, Prospective, Non-controlled, Non-randomised, Clinical Study to Collect Impedance Data of Potentially Malignant Pigmented Nevi and Histological Diagnoses
1 other identifier
interventional
1,800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedAugust 11, 2010
August 1, 2010
4.6 years
August 25, 2009
August 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Outcome measure not applicable. This is an algorithm training study.
Q1 2010
Interventions
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.
Eligibility Criteria
You may qualify if:
- Men and women of any ethnic group
- Lesion located on normal healthy skin
- Maximum number of eight lesions per patient
- etc.
You may not qualify if:
- Lesion under finger and toe nails
- Lesion located on eczema, psoriasis areas or similar
- Lesion located on scars
- etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SciBase ABlead
Study Sites (1)
Sahlgrenska University Hospital, Dpt. of Dermatology
Gothenburg, 41345, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 26, 2009
Study Start
December 1, 2005
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
August 11, 2010
Record last verified: 2010-08