Document Detail

Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multi-centre, prospective and blinded clinical trial on efficacy and safety.
MedLine Citation:
PMID:  24841846     Owner:  NLM     Status:  Publisher    
AIM: To assess the effectiveness and safety of the Nevisense system in the distinction of benign lesions of the skin from melanoma with electrical impedance spectroscopy.
METHOD: This multi-center, prospective, and blinded clinical study was conducted at 5 US and 17 European investigational sites. All eligible skin lesions in the study were examined with the Nevisense electrical impedance spectroscopy system, photographed, removed by excisional biopsy and subjected to histopathological evaluation. A post-procedure clinical follow up was conducted at 7 +/- 3 days from the initial measurement. A total of 1,951 subjects with 2,416 lesions were enrolled into the study; 1,943 lesions were eligible and evaluable for the primary efficacy endpoint (including 265 melanomas - 112 in situ and 153 invasive melanomas with a median Breslow thickness of 0.57 mm, 48 BCC and 7 SCC).
RESULTS: The observed sensitivity of Nevisense was 96.6% (256 of 265 melanomas) with an exact one-sided 95% lower confidence bound estimated at 94.2% and an observed specificity of 34.4% with an exact two-sided 95% confidence bounds estimated at 32.0% to 36.9%. The positive and negative predictive value of Nevisense was 21.1% and 98.2%, respectively. The observed sensitivity for non-melanoma skin cancer was 100% (55 of 48 BCC and 7 SCC) with an exact two-sided 95 confidence bound estimated at 93.5% to 100%.
CONCLUSION: Nevisense is an accurate and safe device to support clinicians in the detection of cutaneous melanoma. This article is protected by copyright. All rights reserved.
Joseph Malvehy; Axel Hauschild; Clara Curiel-Lewandrowski; Peter Mohr; Rainer Hofmann-Wellenhof; Richard Motley; Carola Berking; Douglas Grossman; John Paoli; Carmen Loquai; Judit Olah; Uwe Reinhold; Helena Wenger; Thomas Dirschka; Steven Davis; Catriona Henderson; Harold Rabinovitz; Julia Welzel; Dirk Schadendorf; Ulrik Birgersson
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-5-19
Journal Detail:
Title:  The British journal of dermatology     Volume:  -     ISSN:  1365-2133     ISO Abbreviation:  Br. J. Dermatol.     Publication Date:  2014 May 
Date Detail:
Created Date:  2014-5-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0004041     Medline TA:  Br J Dermatol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
This article is protected by copyright. All rights reserved.
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