International Melanoma Algorithm Training Study - IMATS

This study has been completed.
Sponsor:
Information provided by:
SciBase AB
ClinicalTrials.gov Identifier:
NCT00966173
First received: August 25, 2009
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

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 Intervention
Malignant Melanoma
Device: SciBase III Electrical Impedance Spectrometer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SciBase AB:

Primary Outcome Measures:
  • Outcome measure not applicable. This is an algorithm training study. [ Time Frame: Q1 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: December 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966173

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

No publications provided

Responsible Party: Anders Lundqvist, CEO, SciBase AB
ClinicalTrials.gov Identifier: NCT00966173     History of Changes
Other Study ID Numbers: 6001
Study First Received: August 25, 2009
Last Updated: August 10, 2010
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on September 18, 2014