Scibase International Melanoma Pivotal Study (SIMPS)

• Research type

  Research Study

• Full title

  An international, multicenter, prospective, blinded clinical study designated to determine the safety and effectiveness of the SciBase III device designed to distinguish between malignant melanoma and benign lesions using electrical impedance spectroscopy (EIS)

• IRAS ID

  36699

• Contact name

  Catriona Henderson

• Sponsor organisation

  Scibase AB

• Eudract number

  N/A

• ISRCTN Number

  N/A

• Research summary

  This is a multicenter, prospective, blinded clinical study designed to determine the safety and effectiveness of the SciBase III device designed to distinguish between malignant melanoma and benign skin lesions using electrical impedance spectroscopy (EIS). Recruitment will be from up to 5 US and about 20 European investigational sites. Potential study subjects will be screened according to the study criteria. Subjects meeting all the study criteria can participate in the study. To ensure a relevant mix of lesions, the physician will be encouraged to enroll an equal mix of low/medium/high risk lesions. Subjects who provide written informed consent will be asked about their pertinent medical history and a clinical evaluation will be made by the clinical investigator. Thereafter an evaluation of the suspicious lesion with the device will be performed followed by excision of the lesion. The excised lesion will be histologically analysed. The first histological analysis will be performed by the local histopathologist and the second SIMPS research analysis (Reference standard), will be performed by the panel of three histopathologists (PAD board) with a special interest in dermapathology in the Clarke school of thought. All histopathologists will analyze the histological samples independently. The analysis conducted by the PAD board is anticipated to take place around 1-3 months after measurement of the lesion (only after the histological slides are no longer required at the local site for review and multidisciplinary team meetings). The case report form and the results from the local histopathologist, PAD board and consensus panel will be kept blinded from the sponsor until classification of all lesions in the whole study is made. A post-procedure follow up, either by a telephone or site visit, will be conducted at 73 days from the SciBase III evaluation, at which time the subject will be evaluated for any adverse events.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  09/H0808/106

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Further Information Favourable Opinion