Dear Doctor,

SciBase AB would be delighted to have you participate in this multiple reader multiple case study. The study aims to gain insights into the clinical utility of our new device, Nevisense.

Additional study information/details are as follows:

  • To facilitate an easy review process for you as an investigator, the reader study will be conducted as an online survey.
  • To be eligible to participate as a reader in this study, you must be a US board certified dermatologist practicing in the United States.
  • Your financial compensation for successful study participation will be $1000 multiplied by the percentage of completed cases with an additional $1000 upon completion. In case less than 60% of the cases have been read no compensation will be paid.
  • Up to 45 readers will be selected to participate in the study.
  • The required timeframe for completed evaluation of your assigned ~140 cases is within 4 weeks.
  • The study will start on the 30th March and end in the beginning of May.

Please indicate your interest in participating in the study by completing the form below:

[survey-form]

Upon completion of the form you will receive a confirmation email  within 1-2 working days with further details.

On behalf of SciBase, I look forward to your participation. Please feel free to contact me with any questions.

Thank you for your time and consideration.
Sincerely,
Ulrik Birgersson, PhD.

Study Design Overview

Study Aim

The aim of the reader study is to assess the manner in which Nevisense is incorporated into dermatologists’ considerations when evaluating lesions with a suspicion for melanoma.

Lesion Review

Step 1. Review:

  • Relevant Patient and Lesion Information
  • Clinical image of a lesion

Step 2. Review:

  • Relevant Patient and Lesion Information
  • Clinical image of the lesion
  • Nevisense Result

In each review step and for every lesion the reader will be asked the following questions:

  • Do you think this lesion is a melanoma? (Yes / No)
  • Would you biopsy/refer the lesion? (Yes / No)

Step 1 and 2 are conducted in a sequential manner for each case. Once the reader has completed the questions for a case, the assessment is recorded and considered completed. After the completion of a case the reader will be presented with the next case until all cases have been read. The reader cannot view or change his/her answers for either a completed step or case.

A schematic overview of the study design is depicted in the Figure below.

 

Reading Session

The cases do not have to be read in one single session. The online survey permitts the cases to be read in multiple sessions during the course of 4 weeks.

Selected Scientific Publications with SciBase Technology

  • Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multi-centre, prospective and blinded clinical trial on efficacy and safety fularticle
    Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. British Journal of Dermatology. 2014 May 19.  DOI: 10.1111/bjd.13121. 
  • Electrical Impedance Spectroscopy as a potential adjunct diagnostic tool for cutaneous melanoma full article
    Mohr  P, Birgersson U, Berking C, Henderson C, Trefzer U, Kemeny L, Sunderkötter C, Dirschka T, Motley R, Frohm-Nilsson M, Reinhold U, Loquai C, Braun R, Nyberg F, Paoli J. Skin Res Technol. 2013 Jan 27. doi: 10.1111/srt.12008.
  • Electrical impedance and the diagnostic accuracy for malignant melanoma  abstract
    Åberg P, Birgersson U, Elsner P, Mohr P, Ollmar S. Experimental Dermatology, 2011 Mar 3; 648-652.
  • Skin cancer identification using multi-frequency electrical impedance – a potential screening tool abstract
    Åberg P, Nicander I, Hansson J, Geladi P, Holmgren U, Ollmar S. IEEE Trans Biomed Eng 2004; 51(12): 2097-2102.

Find more publications here.