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International Melanoma Algorithm Training Study - IMATS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00966173
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : August 11, 2010
Sponsor:
Information provided by:
SciBase AB

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.

Condition or disease Intervention/treatment
Malignant Melanoma Device: SciBase III Electrical Impedance Spectrometer

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2005
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: SciBase III Electrical Impedance Spectrometer
    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 Measures :
  1. Outcome measure not applicable. This is an algorithm training study. [ Time Frame: Q1 2010 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966173


Locations
Sweden
Sahlgrenska University Hospital, Dpt. of Dermatology
Gothenburg, Sweden, 41345
Sponsors and Collaborators
SciBase AB

Responsible Party: Anders Lundqvist, CEO, SciBase AB
ClinicalTrials.gov Identifier: NCT00966173     History of Changes
Other Study ID Numbers: 6001
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas