Clinical Utility of Electrical Impedance Spectroscopy

NCT04161742 | Unknown

• 1 other identifier: FG-001
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to evaluate the clinical utility of the Nevisense in normal clinical practice, i.e. the potential effect of implementing Nevisense in clinical decision making (Human vs Human \& Machine) based on Nevisense measurement at time of biopsy decision.

Conditions

Focus of Study: Patients With Suspicion of Melanoma

Outcome Measures

Primary Outcomes (1)

• Number needed to biopsy

  The primary study outcome is the number needed to biopsy to detect a single melanoma case.

  1 day

Interventions

Nevisense DEVICE

Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The lesion(s) meet criteria for Nevisense evaluation.
• Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi) -Thus, necessitating a biopsy.
• Lesions within Nevisense indication for use: Nevisense is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. Nevisense should not be used on clinically obvious melanoma. The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. Nevisense is indicated only for use on:
• primary skin lesions with a diameter between 2 mm and 20 mm;
• lesions that are accessible by the Nevisense probe;
• lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions);
• lesions that do not contain a scar or fibrosis consistent with previous trauma;
• lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;
• lesions not in hair-covered areas;
• lesions which do not contain foreign matter;
• lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).

You may not qualify if:

• Subjects who fail to provide informed consent
• Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit Nevisense from collecting data

Sponsors & Collaborators

• SciBase AB: lead

Related Publications (2)

• 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. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.

  PMID: 24841846 BACKGROUND

• Rocha L, Menzies SW, Lo S, Avramidis M, Khoury R, Jackett L, Guitera P. Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions. Br J Dermatol. 2017 Nov;177(5):1432-1438. doi: 10.1111/bjd.15595. Epub 2017 Oct 11.

  PMID: 28421597 BACKGROUND

Study Officials

• Laura Ferris, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Ferris, MD

CONTACT

+1 412-647-4200; ferrlk@UPMC.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: December 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share