SpotCheck: Comparison of Enhanced Telemedicine Versus In-person Evaluation for the Diagnosis of Skin Cancer
Phase: NA
Conditions: Skin Cancer
Sponsor: NYU Langone Health

 
 
Official Title: 
SpotCheck: Comparison of Enhanced Telemedicine Versus In-person 
Evaluation for the Diagnosis of Skin Cancer   
NCT Number: 
NCT04411810 
Study Number: 
19-01242 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
September 13, 2022 
 

 
 
Page i 
  
 
SPOTCHECK: COMPARISON OF ENHANCED TELEMEDICINE VERSUS IN-
PERSON EVALUATION FOR THE DIAGNOSIS OF SKIN CANCER: A PILOT, 
PROOF-OF-CONCEPT STUDY  
 
Principal Investigator: 
 
David Polsky, MD, PhD 
Dermatology 
522 First Avenue, SML-404 
New York, NY 10016 
David.polsky@nyulmc.org 
212-263-9087 
Additional Investigators: 
 
Tracey Liebman, MD, FAAD 
Dermatology 
240 38th Street, Eleventh Floor 
New York, NY 10016 
Tracey.liebman@nyumc.org  
212-263-5015 
 
Jennifer Stein, MD 
Dermatology 
240 38th Street, Eleventh Floor 
New York, NY 10016 
Jennifer.Stein@nyumc.org 
212-263-5889 
 
 
Yongzhao Shao, PhD 
Population Health 
650 First Avenue, Fifth Floor  
New York, NY 10016 
Yongzhao.Shao@nyulangone.org  
212-263-0324 
NYULMC Study Number: 
s19-01242  
Supporting Grants:  
Melanoma Research Alliance, Zlinkoff Fund for Medical Research 
IND/IDE Number:  
Approved investigational device 
Study Product Provider:  
Scibase (Nevisense provider) 
 
 
Initial version: October 10, 2019 
Amended: 
March 6, 2020 
Amended: 
 August 10, 2020 
Amended:  
September 28, 2020 
Amended:  
December 29, 2020 
Amended:  
May 05, 2021 
Amended: June 24, 2021 
Amended: November 1, 2021 
 
Amended April 13, 2022 
 
Amended: May 16, 2022 
 
Amended: August 17, 2022 
 
 

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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other 
applicable US government research regulations, and institutional research policies and procedures. The 
International Conference on Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) 
(sometimes referred to as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with 
FDA and DHHS regulations. The Principal Investigator will assure that no deviation from, or changes to 
the protocol will take place without documented approval from the Institutional Review Board (IRB), 
except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel 
involved in the conduct of this study have completed Human Subjects Protection Training. 
 
 

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Table of Contents 
 
STATEMENT OF COMPLIANCE ............................................................................................ II 
TABLE OF CONTENTS ........................................................................................................... III 
LIST OF ABBREVIATIONS ..................................................................................................... VI 
PROTOCOL SUMMARY ............................................................................................................ 1 
SCHEMATIC OF STUDY DESIGN ........................................................................................... 3 
1 
KEY ROLES ......................................................................................................................... 5 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE ................................................................................................................................. 5 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ........................................... 5 
2.2 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL AGENT .......................................... 5 
2.2.1 
Clinical Data to Date ............................................................................................ 6 
2.3 
RATIONALE ...................................................................................................................... 6 
2.4 
POTENTIAL RISKS & BENEFITS ....................................................................................... 7 
2.4.1 
Known Potential Risks ......................................................................................... 7 
2.4.2 
Known Potential Benefits .................................................................................... 7 
3 
OBJECTIVES AND PURPOSE ......................................................................................... 7 
3.1 
PRIMARY OBJECTIVE ...................................................................................................... 7 
3.2 
SECONDARY OBJECTIVES ............................................................................................... 7 
4 
STUDY DESIGN AND ENDPOINTS ................................................................................ 8 
4.1 
DESCRIPTION OF STUDY DESIGN ................................................................................... 8 
4.2 
STUDY ENDPOINTS ......................................................................................................... 8 
4.2.1 
Primary Study Endpoints .................................................................................... 8 
4.2.2 
Secondary Study Endpoints ............................................................................... 8 
5 
STUDY ENROLLMENT AND WITHDRAWAL ............................................................... 8 
5.1 
INCLUSION CRITERIA ....................................................................................................... 8 
5.2 
EXCLUSION CRITERIA ..................................................................................................... 9 
5.3 
VULNERABLE SUBJECTS ................................................................................................. 9 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION ........................................................ 9 
5.5 
DURATION OF STUDY PARTICIPATION .......................................................................... 10 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ............................................................. 10 
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION ............................................................. 10 
5.7.1 
Reasons for Withdrawal or Termination ......................................................... 10 
5.7.2 
Handling of Participant Withdrawals or Termination..................................... 10 
5.8 
PREMATURE TERMINATION OR SUSPENSION OF STUDY .............................................. 10 
6 
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE ETC.) AND/OR 
PROCEDURAL INTERVENTION ........................................................................................... 10 
6.1 
STUDY AGENT(S) AND CONTROL DESCRIPTION .......................................................... 10 

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6.1.1 
Acquisition ........................................................................................................... 11 
6.1.2 
Formulation, Appearance, Packaging, and Labeling .................................... 11 
6.1.3 
Product Storage and Stability ........................................................................... 11 
6.1.4 
Device Specific Considerations ....................................................................... 11 
6.2 
STUDY AGENT ACCOUNTABILITY PROCEDURES .......................................................... 12 
7 
STUDY PROCEDURES AND SCHEDULE ................................................................... 13 
7.1 
STUDY PROCEDURES/EVALUATIONS ............................................................................ 13 
7.1.1 
Study Specific Procedures ................................................................................ 13 
7.2 
LABORATORY PROCEDURES/EVALUATIONS ................................................................. 13 
7.2.1 
Clinical Laboratory Evaluations ........................................................................ 13 
7.2.2 
Specimen Preparation, Handling, and Storage ............................................. 13 
7.3 
STUDY SCHEDULE ......................................................................................................... 13 
7.3.1 
Screening............................................................................................................. 14 
7.3.2 
Enrollment/Baseline ........................................................................................... 14 
7.3.3 
Intermediate Visits .............................................................................................. 14 
7.3.4 
Study Completion ............................................................................................... 15 
7.3.5 
Withdrawal/Early Termination Visit .................................................................. 15 
7.3.6 
Unscheduled Visit .............................................................................................. 15 
8 
ASSESSMENT OF SAFETY ........................................................................................... 15 
8.1 
SPECIFICATION OF SAFETY PARAMETERS ................................................................... 15 
8.1.1 
Definition of Adverse Events (AE) ................................................................... 15 
8.1.2 
Definition of Serious Adverse Events (SAE) .................................................. 15 
8.1.3 
Definition of Unanticipated Problems (UP) .................................................... 16 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT ..................................................................... 16 
8.2.1 
Severity of Event ................................................................................................ 16 
8.2.2 
Relationship to Study Agent ............................................................................. 16 
8.2.3 
Expectedness ..................................................................................................... 16 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP ............. 17 
8.4 
REPORTING PROCEDURES – NOTIFYING THE IRB ....................................................... 17 
8.4.1 
Adverse Event Reporting .................................................................................. 17 
8.4.2 
Serious Adverse Event Reporting ................................................................... 18 
8.4.3 
Unanticipated Problem Reporting .................................................................... 19 
8.5 
STUDY HALTING RULES ................................................................................................ 20 
8.6 
SAFETY OVERSIGHT ..................................................................................................... 20 
9 
CLINICAL MONITORING ................................................................................................. 20 
10 
STATISTICAL CONSIDERATIONS ........................................................................... 21 
10.1 
STATISTICAL HYPOTHESES ........................................................................................... 21 
10.2 
ANALYSIS DATASETS .................................................................................................... 21 
10.3 
DESCRIPTION OF STATISTICAL METHODS .................................................................... 21 
10.3.1 
General Approach .............................................................................................. 21 
10.3.2 
Analysis of the Primary Efficacy Endpoint(s) ................................................. 21 
10.3.3 
Analysis of the Secondary Endpoint(s) ........................................................... 21 
10.3.4 
Safety Analyses .................................................................................................. 22 
10.3.5 
Adherence and Retention Analyses ................................................................ 22 

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10.3.6 
Baseline Descriptive Statistics ......................................................................... 22 
10.3.7 
Planned Interim Analysis................................................................................... 22 
10.3.8 
Additional Sub-Group Analyses ....................................................................... 22 
10.3.9 
Multiple Comparison/Multiplicity ...................................................................... 22 
10.3.10 Tabulation of Individual Response Data ......................................................... 22 
10.3.11 Exploratory Analyses ......................................................................................... 22 
10.4 
SAMPLE SIZE ................................................................................................................. 22 
10.5 
MEASURES TO MINIMIZE BIAS ...................................................................................... 23 
10.5.1 
Enrollment/Randomization/Masking Procedures .......................................... 23 
10.5.2 
Evaluation of Success of Blinding ................................................................... 23 
10.5.3 
Breaking the Study Blind/Participant Code .................................................... 23 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ... 23 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ............................................. 23 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ................................................... 24 
13.1 
ETHICAL STANDARD ...................................................................................................... 24 
13.2 
INSTITUTIONAL REVIEW BOARD .................................................................................... 24 
13.2.1 
Telephone Pre-Screen: ..................................................................................... 24 
13.3 
INFORMED CONSENT PROCESS.................................................................................... 24 
13.3.1 
Consent/Assent and Other Informational Documents Provided to 
Participants .......................................................................................................................... 24 
13.3.2 
Consent Procedures and Documentation ...................................................... 24 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................. 25 
13.4.1 
Research Use of Stored Human Samples, Specimens, or Data ................ 25 
13.5 
FUTURE USE OF STORED SPECIMENS ......................................................................... 25 
14 
DATA HANDLING AND RECORD KEEPING .......................................................... 26 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES ......................................... 26 
14.2 
STUDY RECORDS RETENTION ...................................................................................... 26 
14.3 
DATA SAFETY MONITORING: ........................................................................................ 26 
14.4 
PROTOCOL DEVIATIONS................................................................................................ 27 
14.5 
PUBLICATION AND DATA SHARING POLICY .................................................................. 27 
15 
STUDY FINANCES ....................................................................................................... 27 
15.1 
FUNDING SOURCE ......................................................................................................... 27 
15.2 
COSTS TO THE PARTICIPANT ........................................................................................ 27 
15.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ......................................................... 28 
16 
STUDY ADMINISTRATION ......................................................................................... 28 
16.1 
STUDY LEADERSHIP ...................................................................................................... 28 
17 
CONFLICT OF INTEREST POLICY ........................................................................... 28 
18 
REFERENCES ............................................................................................................... 28 
19 
SUPPLEMENTAL ATTACHMENTS .......................................................................... 30 
20 
SCHEDULE OF EVENTS ............................................................................................. 31 
 

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List of Abbreviations 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DCSU 
Department of Dermatology Clinical Trials Unit 
EIS 
Electrical Impedance Spectroscopy (EIS) 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
MOP 
NYU 
NYULMC 
Manual of Procedures 
New York University 
New York University Langone Medical Center 
NIH 
National Institutes of Health 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
US 
United States 
 
 

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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as authorized in writing by the study sponsor 
Interventional Template Version: 05 JAN 2017 
 
Protocol Summary 
Title 
SpotCheck: Comparison of enhanced telemedicine versus in-person 
evaluation for the diagnosis of skin cancer  
Brief Summary 
The aim of this pilot is to test a novel, telemedicine-based skin cancer 
diagnostic platform (SpotCheck) that has the potential to improve access to 
needed dermatologic care for those living in medically underserved areas. In 
this study we will recruit participants with 1-3 skin lesions concerning for skin 
cancer. Each concerning lesion will be evaluated by an enhanced 
telemedicine method using clinical images, a dermoscopic image, and a 
measurement by Nevisense, a low-cost skin cancer diagnostic device 
currently FDA-cleared for use in dermatologists’ offices. Each subject will also 
be evaluated in-person by a clinical dermatologist with dermoscopy so the 
accuracy of the telemedicine diagnosis can be compared to the current gold 
standard. This pilot project will assess both diagnostic congruence and 
patient-centered outcomes regarding this service, which will provide 
preliminary data for larger follow up studies, including those in medically 
underserved areas.  
Phase 
Pilot Proof of Concept Study 
Objectives 
Aim 1: Determine the agreement between in-person and teledermatologist 
evaluations of concerning skin lesions identified by participants in a walk-in 
clinic setting 
Aim 2: Determine the degree to which the enhanced telemedicine method 
addresses patient needs and preferences (i.e. patient-centered outcomes) 
Methodology 
Prospective single arm study of a diagnostic intervention against the gold 
standard dermatological care, singly blinded to diagnosticians.  
Endpoint 
Primary endpoint: Congruency between biopsy recommendation of enhanced 
telemedicine evaluation and in-person dermatology evaluation 
Secondary endpoints: 1) Specificity, sensitivity, false-positive rate, false-
negative rate, positive predictive value, and negative predictive value of 
enhanced telemedicine evaluation and in-person evaluation to diagnose skin 
cancer; 2)Participant satisfaction of intervention in addressing patient 
centered outcomes 
Study Duration 
Study is estimated to be open for 24 months or longer to be sufficiently 
powered  
Participant Duration 
Estimated duration is one to four weeks subject to participant’s findings 
Duration of IP 
administration 
Clinical and dermoscopic image acquisition for teledermatologist evaluation 
will take <2 minutes per lesions, and Nevisense data acquisition will take <2 
minutes per lesion  
Population 
At least 18 years of age 
Females and Males 
Study Sites 
NYU School of Medicine 
The Ronald O. Perelman Department of Dermatology  
Ambulatory Care Center 
Dermatology Clinical Trials Unit 
240 East 38th Street, 12th Floor, 
New York, NY 10016 
Number of participants 
650 enrolled participants 
Description of Study 
Agent/Procedure 
Telemedicine evaluation using combined dermoscopic imaging with Dermlite 
Cam (3Gen) and/or Barco Demetra and electrical impedance spectroscopy 
using Nevisense 3.0 
Reference Therapy 
In-person dermatologist evaluation  

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Key Procedures 
Clinical and dermoscopic imaging of skin lesions, Nevisense measurement of 
skin lesion electrical impedance. Possible skin biopsy for lesion(s) identified 
as concerning for malignancy 
Statistical Analysis 
Percent agreement of biopsy recommendation in diagnostic intervention 
compared to control. For biopsied lesions, sensitivity and specificity of in-
person dermatologist and teledermatologist evaluation for skin cancer 
diagnosis will also be determined. Success by patient centered outcomes will 
be analyzed by questionnaires using Likert scales. 
 
 
 

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Schematic of Study Design 
 
Visit 1 
Visit 2 

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Telemedicine Team Clinical Decision-Making Algorithm 
 
 
 
 

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1 Key Roles 
Dr. Yongshao Shao (biostatistician) will not be engaged in the research (i.e. will not be interacting with subjects nor have 
access to identifiable subject information). 
2 Introduction, Background Information and Scientific Rationale 
2.1 
Background Information and Relevant Literature 
Recognition and diagnosis of early stage melanomas is associated with >98% 10-year survival for tumors <0.8mm in 
thickness. In contrast, more advanced stages have 10-year survivals ranging between 94% - 75% for localized disease, 
and much lower rates for regional and distant metastatic disease1. Nearly all patients diagnosed with early stage disease 
are cured surgically. Besides exhibiting reduced mortality, these patients experience less complicated and less costly care, 
and will not be exposed to the potential toxicities of the new systemic therapies for advanced disease2. 
 
Associations between access to healthcare and cancer health outcomes are well established. In melanoma, several studies 
reveal that populations with lower socioeconomic levels, decreased physician supply, and increased distance to a 
diagnosing provider are diagnosed with more advanced stage disease than populations with better access3. There is a need 
to reduce the barriers to access for diagnostic services when patients have a skin lesion of concern, especially in areas of 
decreased physician supply. In areas with ample physician supply, however, many benign growths are unnecessarily 
removed out of concern for melanoma because most providers do not use modern technologies to augment their diagnostic 
skills. Dermoscopy, which is a non-invasive, 10x magnification technique to visualize skin structures and colors not visible 
to the naked eye, improves diagnostic accuracy and thus decreases ratios of benign-to-malignant biopsy excisions4.  
 
Over the last several years, store-and-forward telemedicine technology has advanced, enabling expert diagnostic services 
to be provided to areas of low physician supply by providing images to providers working remotely. A recent Cochrane 
Review of store-and-forward teledermoscopy studies noted that these technologies are likely to appropriately triage lesions 
for in-person assessment by a health care provider5.  
The long-term goal of this project is to reduce poor melanoma outcomes among underserved communities by delivering 
state-of-the-art diagnostic expertise to these neighborhoods via telemedicine. In the proposed pilot study, we plan to model 
a walk-in clinic, like the CVS Minute Clinic, in the NYU Dermatology Clinical Studies Unit (DCSU). We will test the 
effectiveness of an enhanced teledermatology service to accurately evaluate up to 3 self-identified skin lesions of concern 
per member of the general public. In addition to obtaining clinical and dermoscopic images of the skin lesions, we will 
enhance the evaluation with a Nevisense device. Nevisense, which uses a small hand-held probe and electrical impedance 
spectroscopy (EIS), received FDA clearance (PMA) in 2017 “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”7. The validation study showed a sensitivity of 97% and specificity of 34% for the diagnosis of melanoma. The 
negative predictive value, important for a screening tool, was 98%8. Importantly, the lesions in this study were preselected 
by dermatologists. It is known that Nevisense can deliver false positive results for common benign skin lesions that are likely 
to be encountered frequently in a walk-in clinic setting. These lesions are easily diagnosed using teledermoscopy, so we 
will investigate whether the combined dermoscopic and Nevisense evaluation will have a higher sensitivity and specificity 
than either technique alone, and will be comparable to, or potentially more accurate than, an in-person evaluation by a 
clinical dermatologist. A similar service is available in Norway through ScreenCancer (www.screencancer.com). The 
Norwegian pharmacies use a dermatologist review of computer-enhanced dermoscopy images without Nevisense. Between 
2010-2014, they conducted 25,836 scans in 109 pharmacies, recommended biopsies of 8% of lesions, and diagnosed 154 
melanomas. In 2014, they diagnosed 4% of all Norwegian melanoma cases9. These results demonstrate the potential of 
our SpotCheck platform to improve the outcomes of melanoma patients, especially those with fair skin residing in medically 
underserved communities.  
 
The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic 
services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are 
worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services 
would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. 
With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced 
melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma 
mortality.  
2.2 
Name and Description of the Investigational Agent  
The investigational agent is the combined use of clinical images, dermoscopic imaging with Dermlite Cam (3Gen) and/or 
the Barco Demetra and electrical impedance spectroscopy using Nevisense 3.0 (Scibase) for the purpose of a telemedicine 
evaluation.  

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Clinical images for the purpose of teledermatology will be captured with a study specific camera or through the use of Epic 
Haiku which is an application that can be downloaded onto NYU approved electronic mobile devices to capture clinical 
images. The images are directly imported into the patient’s medical record, without being stored on the device itself. The 
clinical images stored in EPIC EMR patient medical record will include a research note detailing the location of each lesion 
and 3 photos of each lesion at various distances, approximately 6 inches, 12 inches, and 18 inches from the lesion. Dermlite 
Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt.  
 
The Barco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images 
and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by trained medical 
practitioners. The Barco Demetra received 510(k) Premarket approval (510(K) Number: K192829). The 510(k) Premarket 
Approval can be found in Supplement V. The 510(k) Summary can be found in Supplement W.  This device is intended to 
be used in a normal working environment of medical practitioners examining skin conditions. The Demetra system involves 
a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered 
medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software 
application is cloud software with an associated web application, and this software can be used to visualize images and 
related data and can generate consultation reports. For the purposes of teledermatology, dermoscopic and clinical 
photographs (at approximately 6 inches, 12 inches, and 18 inches) will be taken using the Barco Demetra.  
 
Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence 
spectroscopy (EIS) score. Electrical impedance is a measure of a material’s overall resistance to the flow of alternating 
electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal 
tissue. An earlier version, Nevisense 2.0 received premarket approval (PMA) status from the FDA (PMA Number: P150046). 
The Summary of Safety and Effectiveness of this device is attached in Supplement A. The Administration and Service 
Instructions is listed as Supplement B. The pivotal study was conducted under IDE #G090108. This device is indicated for 
use on cutaneous lesions with characteristics of melanoma when a dermatologist chooses to obtain additional information 
when considering biopsy. However, Nevisense 2.0 will not be used in this research study. Rather, Nevisense 3.0 will be 
used. Nevisense 3.0 has an updated software that no longer requires a reference non-lesion skin area measurement and 
has higher specificity as compared to Nevisense 2.0. There is no change in the hardware. Nevisense 3.0 received t FDA 
approval in April 2020. We will be using Nevisense 3.0 due to the added advantage of saving time and its enhanced 
diagnostic performance. Any risk of the unapproved Nevisense 3.0 device will be mitigated by the fact that other diagnostic 
tools will be used on every lesion of concern (clinical images and dermoscopic images) and the fact that each concerning 
lesion will be assessed by an in-person dermatologist, the current gold standard for diagnostic evaluation. Any data collected 
as part of this study will not be used in support of this PMA supplement or amendment. 
2.2.1 
Clinical Data to Date 
The largest prospective study, which formed the basis of the FDA PMA, showed that among lesions pre-screened by a 
dermatologist, EIS has the ability to distinguish between benign lesions and melanoma with a sensitivity of 97% and a 
specificity of 34%8. The same study also showed that as compared to dermoscopic examination alone, EIS showed superior 
sensitivity but not specificity8. Prior studies also demonstrate the EIS technology to have a lower false negative rate when 
compared to the ‘gold standard’ of skin cancer screening using visual inspection plus dermoscopy.10 A more recent study 
showed that Nevisense can be a useful tool to help guide decision-making for clinically atypical nevi with low/intermediate-
level concern for early stage melanoma that would otherwise qualify for three-month sequential dermoscopic 
imaging/monitoring. This technique is typically employed in patients with multiple atypical nevi. The combined use of 
Nevisense and dermoscopic monitoring for changes over a 3-month period for these lesions demonstrated a sensitivity of 
100% and specificity of 69%.11 The high sensitivity and reasonable specificity make it an ideal tool to augment screening 
examinations. Notably all studies with Nevisense have required lesions to be pre-screened as suspicious for melanoma by 
dermatologists. Of note, although the study was designed to measure the performance of Nevisense in diagnosing 
melanoma, it correctly identified 100% of 55 non-melanoma skin cancers (e.g. basal cell carcinoma, etc.). 
2.3 
Rationale 
Detection of melanoma at its earliest stages is associated with high surgical cure rates, without the need for additional, 
potentially toxic and expensive systemic therapies. Rural and other medically underserved communities have higher rates 
of melanoma mortality that is associated with reduced access to dermatologic diagnostic services. We aim to study the 
effectiveness of an augmented telemedicine diagnostic platform for melanoma and other skin cancers that can potentially 
be deployed in pharmacies and urgent care centers that would be more available in rural communities than dermatologist 
offices.  
 
The study will evaluate participant-selected lesions of adults in the New York City metropolitan area to simulate the walk-in 
clinic or pharmacy community setting. The control is an in-person evaluation by a community dermatologist, the current gold 

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standard. We aim to assess the sensitivity and specificity of the platform compared to the in-person dermatological 
examination in the diagnosis of melanoma and other skin cancers. Since the Nevisense evaluation is one component of the 
platform, and the current FDA approval is for it to be used in dermatologist offices to aid in biopsy decisions, we will also 
examine the degree to which teledermatologists can use the clinical and dermoscopy images to evaluate whether each 
study lesion would have been appropriate for the Nevisense evaluation had they seen the patient in-person. Finally, we will 
examine whether the combined teledermoscopy/clinical images plus Nevisense will have greater sensitivity and specificity 
to diagnose melanoma and other skin cancers than either approach alone.  
 
2.4 
Potential Risks & Benefits 
2.4.1 
Known Potential Risks 
All subjects will have Nevisense EIS measurements for each skin lesion included in the study. Nevisense 3.0 is a non-
significant risk device. It is not intended as an implant and does not present a potential for serious risk to the health, safety, 
or welfare of a subject. Is not purported or represented to be for a use in supporting or sustaining human life and 
does not present a potential for serious risk to the health, safety, or welfare of a subject, is not for a use of substantial 
importance in curing, mitigating, or treating disease and does not present a potential for serious risk to the health, safety, 
or welfare of a subject. 
 
In data presented to the FDA, 1.5% of study participants experienced an adverse event. Most of these events (33/36) were 
mild in severity. Three events that qualified as moderate or severe were deemed to be unrelated to the device. Mild events 
that may or may not have been related to the device included bleeding during measurement, itching at the measurement 
site, pain, soreness, bruising, slight tingling, or headache. Nevisense safety information is outlined in its instructions for use 
and can be found in detail in Supplement C. 
 
We estimate that approximately 10% of subjects will undergo skin biopsy. This is the gold standard diagnostic test for skin 
lesions deemed suspicious for cancer. Immediate physical risk is involved for participants undergoing skin biopsy, which 
includes bleeding, irritation, bruising, allergic reaction to topic antibiotic or adhesive, possible infection, need for repeat 
biopsy if the initial biopsy is non-diagnostic, and/or wound dehiscence. Long-term physical risk includes scarring at the site 
of biopsy. Immediate psychological risk may include mood changes that are anxious or depressive in nature from the 
possibility of a lesion suspicious of melanoma. Immediate economic risk may include parking and transportation fees to 
allow for the clinical visits, and obtaining treatment of possible skin cancer(s) that may be identified during this study. We 
do not anticipate long-term physiological, social, legal, economic or other risks as a result of the participation in the study. 
The value of early detection of melanoma and its attendant increased survival supersedes the minor risks anticipated in the 
study. Alternative to skin biopsy is observation for change, which would only be appropriate in a medical office, and not a 
pharmacy setting. Observation runs the risk of tumor growth, diagnosis of melanoma at a later stage, and worse prognosis.  
2.4.2 
Known Potential Benefits 
Study subjects will have up to three lesions of concern screened by a dermatologist for skin cancer at no cost. We anticipate 
participation in the study to offer immediate and long-term psychological benefit for subjects who have benign lesions and 
who receive reassurance. We estimate ~90% of subjects will have lesions not requiring biopsy and will receive such 
reassurance. Of the remaining subjects, it is likely that 8% will undergo a biopsy and receive a benign diagnosis, which will 
also be reassuring. 
 
For subjects who are found to have malignant diagnoses (~2%), we anticipate substantial long-term physical, psychological, 
and economic benefit from this free screening service. These subjects would benefit from earlier detection of a malignancy 
that otherwise may have gone un-diagnosed. Inevitably the potential for early detection of melanoma or other skin cancers 
is associated with less costly treatment and less complicated care, decreased morbidity and mortality and overall improved 
outcomes.  
3 Objectives and Purpose 
3.1 
Primary Objective 
The primary objective of the study is to assess the concordance in biopsy recommendations between the in-person 
dermatologist evaluation and the enhanced telemedicine evaluation of participant-identified skin lesions concerning for skin 
cancer in a walk-in clinic setting. 
3.2 
Secondary Objectives  
1. To compare the diagnostic accuracy of the enhanced telemedicine method, and its separate individual components 
(Nevisense, teledermoscopy), to the in-person dermatologist with respect to the diagnosis of skin cancer (confirmed 
histopathologically). 

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i. 
At the conclusion of the study, and as an additional control, the in-person dermatologist will review the 
enhanced telemedicine data to compare her in-person diagnoses with diagnoses she would have provided 
had she been functioning as the teledermatologist. 
2. To assess patient satisfaction and preferences (patient-centered outcomes) regarding the teledermatologist 
evaluation for skin lesions suspicious for skin cancer  
3. To determine the proportion of participant-selected skin lesions for which the Nevisense measurement would be 
considered appropriate by the in-person and teledermatologists. 
4. To create a database of dermoscopic images and Nevisense scores of the benign and malignant skin lesions 
encountered in the walk-in clinic setting. 
4 Study Design and Endpoints 
4.1 
Description of Study Design 
4.2 
This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-
selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment 
(gold standard evaluation). The study will be a single arm design with each participant undergoing 
telemedicine data acquisition (i.e. clinical and dermoscopic imaging and Nevisense measurement), 
immediately followed by the in-person dermatologist assessment. The in-person dermatologist will be 
blinded to the Nevisense score at the time of the visit. Using the telemedicine data, the teledermatology team 
will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They 
will be blinded to the results of the in-person dermatologist’s diagnostic evaluation. Study Endpoints 
4.2.1 
Primary Study Endpoints 
The primary endpoint is the agreement in the biopsy/no biopsy recommendations between the teledermatology team using 
the telemedicine data and the in-person dermatologist. We will report a biopsy sensitivity and specificity based on the in-
person evaluation as the gold-standard. The primary objective of the study is to describe the discrepancy between the 
telemedicine diagnostic evaluations and the in-person dermatologist evaluation for the assessment of participant-identified 
skin lesions concerning for skin cancer.  
4.2.2 
Secondary Study Endpoints 
Secondary endpoints include:  
1. The performance metrics of the telemedicine system in diagnosing skin cancer. We will calculate the sensitivity, 
specificity, positive and negative predictive values of the telemedicine system and the in-person dermatologist. We 
will also separately calculate those metrics for the individual components of the telemedicine system, namely, the 
teledermoscopy imaging and the Nevisense measurement.  
2. The satisfaction of the participants with the telemedicine evaluation. This endpoint, based on questionnaire 
responses, will contribute to achieving the secondary objective of determining the degree to which the telemedicine 
system would satisfy patient needs and preferences.  
3. The proportion of lesions for which the Nevisense evaluation would be considered appropriate and helpful in arriving 
at the final biopsy recommendation. This endpoint will help achieve the secondary objective of determining the 
usefulness of Nevisense in the evaluation of participant-selected lesions concerning for skin cancer. 
5 Study Enrollment and Withdrawal 
5.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Be 18 years of age or older 
2. Have 1-3 lesions for evaluation 
3. Fluent in English language 
 
Please note that the study will employ 2 diagnostic modalities: 1) clinical images (via photos of varying distances for each 
lesion uploaded to Epic EMR) and dermoscopic imaging   via dermoscopic photos captured with the DermLite Cam and/or 
the Barco Demetra ; and 2) EIS as determined by the Nevisense device. We anticipate that subjects will present with skin 
lesions that do not meet the inclusion criteria for Nevisense (described in Section 6.1.4) but are suitable for clinical and 
dermoscopic imaging. For example, the original investigational studies with Nevisense 2.0 did not include large numbers of 
individuals from ages 18-30 or Fitzpatrick skin types 5-6, and thus safety and effectiveness has not been well established 
in these groups. While the FDA PMA has cautioned the use of Nevisense for diagnostic purposes in these patients, there 
is no contraindication to use in these populations. Any potential risk from using this device in these populations will be 

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mitigated by the fact that other diagnostic tools will be used on every lesion of concern (clinical images and dermoscopic 
images) and the fact that each concerning lesion will be assessed by an in-person dermatologist, the current gold standard 
for diagnostic evaluation. 
 
5.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
• 
Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear, which 
contain foreign matter 
• 
Lesions that were previously biopsied 
• 
Pregnant women, children, fetuses, neonates and prisoners are not included in the study 
• 
Nevisense device exclusion (photos will be taken and dermatologist exam will be conducted but no 
Nevisense device measurements will be attempted): 
a. primary skin lesions with a diameter greater than 20 mm;  
b. lesions where the skin is ulcerated or bleeding lesions;  
c. lesions that contain a scar or fibrosis consistent with previous trauma;  
d. lesions located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;  
  
5.3 
Vulnerable Subjects 
Pregnant women, children, fetuses, neonates and prisoners are not included in the study. The elderly are included in the 
study as they are at particular risk for melanoma and the devices used in the evaluation do not pose significant risks, and 
the risks of skin biopsy (should they be recommended) are minimal. 
5.4 
Strategies for Recruitment and Retention 
Recruitment of study participants will be from advertisements in local newspapers (e.g., the New York Post, Daily News) 
and with social media virtual publications on Facebook and Instagram. The advertisement includes general information 
about the clinical trial and eligibility criteria, the Dermatology Clinical Studies Unit phone number, and a QR code that 
interested participants will be able to scan using their mobile devices. The QR code will link to the clinicaltrials.med.nyu.edu 
page that states more detailed information about the investigative approach and the study team as well as an online form 
to contact the study team. We will also work with the Perlmutter Cancer Center to advertise the study to individuals on their 
lists. Please find the advertisements intended for publication as Supplement D and E. Additionally, participants will be 
recruited via the Research Match online platform, of which NYU is a participating institution. If needed, we will also use the 
Epic electronic health records to recruit patients from NYULMC. Participants meeting eligibility criteria after a pre-screening 
phone call (Section 7.3.1) will be directed to schedule an appointment with the DCSU for enrollment. The DCSU hosts a 
wide variety of dermatology studies and does not hold any particular stigma for participants. Our enrollment target is 500 
subjects at a rate of 5 subjects per week. We anticipate pre-screening 650 participants to reach our enrollment goal.  
 
At the DCSU, study participants: 1)will be informed of the details of the study and given time to review the IRB approved 
Informed Consent form; 2) given the opportunity to ask questions; and 3) will be enrolled after signing an informed consent 
form (ICF) in a private encounter. After the participant consenting process, lesion eligibility will be confirmed by the study 
team, and participants will provide the study team with contact information, demographic information, past medical history 
of skin cancer, family history of skin cancer, natural hair color, eye color, likelihood of burning with unprotected sun exposure, 
likelihood of tanning with unprotected sun exposure, tanning bed exposure, moderate to severe sunburn exposure, history 
of atypical or dysplastic nevi, estimate of number of moles on body, estimate of number of freckles on face, and identification 
of up to three lesions (location, onset, quality, and prior treatment) by completing the Enrollment Questionnaire (Supplement 
K). Study personnel will have access to these data in order to contact participants for follow up communications including 
the telemedicine report, biopsy results, wound healing check, scheduling, and administering the study completion 
questionnaire. Study personnel will also have access to telemedicine data on each participant including clinical images, 
dermoscopic images, and Nevisense scores. Information about participants will be recorded either on source documents or 
directly into REDCap depending on what is more convenient for the study team and on whether there are temporary 
technological barriers to direct REDCap documentation. Any source documents will be kept in the patient’s study binder 
and file cabinets at DCSU. The data will later be entered into the REDCap database case report forms. Only study personnel 
will have access to the source documents and the REDCAP forms. Study participants will be assigned a participant study 
ID number. 
 
In total, the study requires participant involvement for about 1-4 weeks, depending on whether a biopsy is recommended 
and the participant’s availability. Retention measures include calling participants 3 separate times to ensure a return visit 
for biopsy (if recommended), to communicate teledermatology and/or biopsy results and check wound healing, and/or to 

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conduct the study completion questionnaire. In the event of three failed attempts to reach the participant regarding biopsy 
results, the participant will be sent a certified letter communicating the biopsy results and need for follow-up medical care 
(if needed) (Supplement F). In the event that we are unable to make contact with the subject to communicate the 
teledermatology recommendation, we will send a certified letter with the recommendation printed (Supplement G). ). In the 
event that the teledermatology team recommends a biopsy and a participant cannot be contacted to schedule the biopsy or 
does not show up for a scheduled biopsy appointment, we will send a certified letter instructing them to contact us 
(Supplement H).  At any point during the participant’s involvement in the study, they can reach the DCSU by telephone to 
contact study personnel with concerns regarding wound healing, results interpretation, etc. Medical issues will be referred 
to one of the physician site investigators (e.g. dermatology resident or attending medical monitor). For emergencies, 
participants may contact Dr. Shirin Bajaj with information provided in the emergency card. (Supplement H) 
5.5 
Duration of Study Participation 
From screening to the end of the study completion questionnaire, participation may last between 1-4 weeks depending on 
whether a biopsy is performed.  
5.6 
Total Number of Participants and Sites  
Recruitment will end when 500 participants are eligible for study participation. The only site is the NYU School of Medicine. 
5.7 
Participant Withdrawal or Termination 
5.7.1 
Reasons for Withdrawal or Termination 
Participants may withdraw voluntarily from the study at any time upon request. An investigator may terminate participation 
in the study if: 
• 
Any sudden clinical adverse event (AE), laboratory error, or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the participant 
5.7.2 
Handling of Participant Withdrawals or Termination 
Participants can withdraw voluntarily at any time during the study. If a participant withdraws prior to receiving a 
recommendation to have their lesion(s) biopsied, the biopsy will not take place. However, in the interest of participant safety, 
we will attempt to contact the participant on 3 separate occasions and, if needed, send a certified letter to deliver the biopsy 
recommendation (Supplement G). If a participant withdraws after biopsy is conducted but before the pathology results are 
available, all efforts to contact the participant with results and check on wound healing will continue. In the unlikely event 
that a participant presents with a clinically obvious melanoma (for which a biopsy would be recommended) and chooses to 
withdraw prior to completing the evaluation and/or undergoing a biopsy, we will still recommend a biopsy to this participant 
and will facilitate an appointment in our clinic if participant is amenable.  
 
In the event of a significant number of withdrawals or terminations and enrollment has already closed, enrollment will re-
open to capture 500 participants.  
5.8 
Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. If the study is 
prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the reason(s) for the termination 
or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Insufficient compliance to protocol requirements 
• 
Technological malfunction 
• 
Insufficient data quality 
• 
Unanticipated loss of human resources such as study staff or clinical dermatologists. 
 
Study may resume once concerns about protocol compliance, technology function, data quality, and/or resources are 
addressed and satisfy the IRB. 
 
6 Study Agent (Study drug, device, biologic, vaccine etc.) and/or Procedural Intervention  
6.1 
Study Agent(s) and Control Description 
The Procedural Intervention is the telemedicine evaluation; the Control is the in-person dermatologist evaluation. The 
Procedural Intervention includes 3 components: 

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1) Clinical images (from 6 inches, 12 inches, and 24 inches from the lesion) captured and uploaded to the subject’s 
EPIC EMR medical chart as a research note or captured by the Barco Demetra and uploaded to its associated 
software  
2) Close up clinical and dermoscopic imaging of the lesion(s) of concern with a dermoscopy camera (DermLite Cam, 
3Gen, San Juan Capistrano, CA or Barco Demetra, Barco NV, Kortrijk, BE) 
3) An electrical impedance spectroscopy measurement of said lesions using the Nevisense 3.0 device (Scibase, 
Sundbyberg Sweden) 
4) Store-and-forward telemedicine evaluation of the imaging and Nevisense measurements by a team of 3 
dermatologists.  
 
The goal is to determine whether the lesion(s) of concern to the participant is a benign skin growth, or a possible skin cancer 
in need of a biopsy to definitively establish the diagnosis. The Nevisense 2.0 device is FDA cleared for use in dermatologists’ 
offices. The Nevisense 2.0 device will not be used in this study. Rather, the updated, not yet approved Nevisense 3.0 device 
will be used. The 3.0 version consists of a software update and provides a simpler a workflow that no longer requires a 
reference measurement from the subject’s normal skin, thus saving time. The 3.0 device has no change in the hardware.. 
Verbal FDA clearance occurred in January 2020 and formal FDA clearance is expected in April 2020. Regardless of 
approval, the proposed use of Nevisense 3.0 in a telemedicine setting for this study represents an off-label use of the device. 
 
It measures electrical impedance of the lesion with single-use electrodes (i.e. changed between each participant). The 
device has a hardware probe that takes the measurement in <10 seconds and a software component that displays the data 
on the control unit screen.  
 
Risks related to the device may be expected in <1.0% of cases. Most common to least common side effects include bleeding 
during measurement, pain, soreness, bruising, slight tingling at measurement site, headache, or itching at the measurement 
site. There may be unknown side effects. The DermLite Cam and Barco Demetra imaging devices pose non-significant risks 
to the participant. Capturing clinical and dermoscopic images with this device will take <1 minute per lesion. 
6.1.1 
Acquisition 
DermLite Cam will be purchased from 3Gen. The Nevisense 3.0 will be provided by SciBase. The disposable electrodes 
will be purchased from SciBase. The commitment letter from SciBase is found as Supplement I.  
 
The Barco Demetra device has been approved by NYU MCIT for research use (see included email from Patrocinio Domingo, 
Lead IT Controls and Regulatory Compliance Analyst).  
6.1.2 
Formulation, Appearance, Packaging, and Labeling 
The Nevisense device is commercially available in the US. The Nevisense appears a control unit with a probe. The 
disposable electrodes are marked both on the package box and in each individual electrode packaging. The package insert 
is found as Supplement B. The product is available on the commercial market for human use in the form planned in this 
trial.  
 
The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the 
camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The package insert is found as 
Supplement J. 
 
The Barco Demetra digital dermatoscope appears as a two-piece device consisting of the Demetra Scope Head and 
Rechargeable grip/battery back with a battery charging station.  The device also comes with a non-contact cone and user 
guide. The package insert is found as Supplement X.  
6.1.3 
Product Storage and Stability 
There is no particular storage needs for stability for either the Nevisense device or DermLite Cam. Both will remain locked 
in the DCSU when not in active use, accessible only to study personnel.  
6.1.4 
Device Specific Considerations 
Nevisense 3.0 will be used with the latest software upgrade as a one-time exposure of <8 seconds per lesion. Disposable 
electrodes that contact the participant are 5mm x 5mm in size.  
 
According to the FDA PMA, current indications for Nevisense use are the following:  
• 
primary skin lesions with a diameter between 2 mm and 20 mm;  
• 
lesions that are accessible by the Nevisense probe;  

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• 
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).  
 
We will follow these indications except for prohibiting areas of psoriasis or eczema as the study personal taking the 
Nevisense measurements in this study will most often not be a physician and will not have the dermatological expertise to 
diagnose these conditions or similar conditions. Any potential risk from using this device in such skin conditions will be 
mitigated by the fact that other diagnostic tools will be used on every lesion of concern (clinical images and dermoscopic 
images) and the fact that each concerning lesion will be assessed by an in-person dermatologist, the current gold standard 
for diagnostic evaluation. 
 
Additionally, lesions with crust, on a stalk, recurrent after biopsy or excision will not be included for Nevisense measurement 
as these lesion types were excluded from the pivotal studies for FDA PMA. . Crust (the medical term for a scab) is defined 
as dried serum or blood, typically overlying skin ulceration, or resulting from the rupture of vesicles or pustules.12 
 
The DermLite Cam will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized dermoscopic, and 
one non-polarized dermoscopic). Images will be stored in a dedicated computer folder in the Dermatology Department 
server share using software (MoleCam, MoleMap, NZ) already in use by the telemedicine team in the NYU Department of 
Dermatology Pigmented Lesion Clinic. The telemedicine dermatology team will review the images using this dedicated 
software.  
 
In addition to the DermLite Cam images, a study specific camera or EPIC HAIKU will be used to acquire 3 clinical images 
of <5 seconds per lesion (from 6 inches away, 12 inches away, and 18 inches away). Images will be stored in the patient’s 
medical record in Epic, to which the teledermatology team has access. Clinical images taken through Epic Haiku or the 
study specific camera will not be stored elsewhere. Images taken with the study specific camera will be deleted from the 
camera once images are uploaded to EPIC. 
 
The Barco Demetra device will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized 
dermoscopic, and one non-polarized dermoscopic) as well as 3 additional clinical images of <5 seconds per lesion (from 6 
inches away, 12 inches away, and 18 inches away). Images will be stored in the authenticated and data-encrypted Demetra 
Cloud accessible via the web by the telemedicine team in the NYU Department of Dermatology Pigmented Lesion Clinic. 
The telemedicine dermatology team will review the images using this dedicated cloud software. Clinical and dermoscopic 
images taken by the Barco Demetra device will not be stored elsewhere. 
 
Lesions with bleeding or ulceration will only have a clinical image taken and not have a dermoscopic image taken. 
 
The telemedicine dermatology team will consist of Dr. David Polsky, Dr. Tracey Liebman, and Dr. Jennifer Stein, who are 
all pigmented lesion experts. They will be listed as co-investigators. They will submit independent, blinded to each other, 
diagnoses for each lesion on REDCap. If at least one teledermatologist believes the lesion to be a malignant diagnosis, the 
lesion will be recommended for biopsy. If the participant has not already had the lesion biopsied by the in-person 
recommendation, the participant will be told this concern for malignancy and telemedicine recommendation for biopsy.  
6.2 
Study Agent Accountability Procedures 
The two devices and photos will be used by study personnel. Nevisense measurements will be taken by all study team 
members that have completed the Nevisense training, as per page 4 of the device Instructions For Use (Supplement C). 
Most often, the individual obtaining Nevisense measurements will be non-physician study team members to simulate the 
eventual use in a pharmacy setting. Data acquired from the devices will be transferred to the participant source documents 
at the time of their visit. The results of the control evaluation will also be recorded at the time of the visit. At the end of each 
day, the data will be entered into the REDCap database case report forms and verified by a second study staff member. 
The devices will stay in a locked office in the DCSU when not in use. The images will be stored on an NYU server, behind 
institutional firewall, and backed up according to standard institutional schedules, minimizing the possibility of data loss. 

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7 Study Procedures and Schedule 
7.1 
Study Procedures/Evaluations 
7.1.1 
Study Specific Procedures 
• 
Assessment of eligibility (number of lesions, location of lesions) 
• 
Informed Consent  
• 
Enrollment questionnaire (Supplement K) 
• 
Nevisense EIS measurement 
• 
Imaging of the lesion(s) of concern using the DermLite Cam and stored on MoleCam software and MoleCam drive 
behind NYU MCIT firewall OR using the Barco Demetra and stored on its associated cloud server 
• 
Imaging of the lesion(s) of concern uploaded to EPIC EMR research note using study specific camera or EPIC HAIKU 
• 
Numbering of skin lesions using Devon Skin Marker to verify same lesion evaluated across all assessments 
• 
Administration of part 1 of study completion questionnaire (Supplement L) 
• 
Skin lesion examination by in-person dermatologist  
• 
Phone call to communicate telemedicine recommendation within 3 business days (phone script as Supplement M & N) 
• 
Skin biopsy, if recommended by either the in-person dermatologist or the telemedicine evaluation  
o 
A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method 
utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these 
wounds are generally closed with absorbable sutures and do not require a return visit for suture removal A skin 
biopsy takes <15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 
1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, 
and providing instructions for home care. Samples will be placed in formalin for routine processing. 
• 
Administration of final study completion questionnaire (Supplement L). 
 
7.1.2 
Standard of Care Study Procedures 
• 
Histopathological diagnosis of biopsied skin lesions 
• 
Phone calls to discuss skin biopsy results and check on wound healing 
• 
If necessary, suture removal visit is scheduled (if nylon sutures were placed during skin biopsy) and/or wound check 
visit. 
7.2 
Laboratory Procedures/Evaluations 
7.2.1 
Clinical Laboratory Evaluations 
• 
Routine dermatopathology examination of skin biopsy specimens 
7.2.2 
Specimen Preparation, Handling, and Storage 
Skin biopsy specimens will be transferred on the day of removal to the NYU Dermatopathology Laboratory for processing 
and diagnosis, which is estimated to take 1-2 weeks. Biopsy samples will be labeled with participant identifying information 
including name and MRN. 
7.3 
Study Schedule 
As described below, the study schedule includes a variable number of visits that depend upon the outcome of the initial 
evaluation. Briefly, 3 outcomes are possible: 
1) The lesion(s) is diagnosed as not suspicious for skin cancer by both the in-person dermatologist and telemedicine 
team, and no biopsy is recommended 
2) The lesion(s) is diagnosed as not suspicious for skin cancer by the in-person dermatologist, but suspicious for skin 
cancer by the telemedicine team, and a biopsy is recommended when the telemedicine team results are 
communicated to the participant 
3) The lesion(s) is diagnosed suspicious for skin cancer by the in-person dermatologist, and a biopsy is performed at 
the initial visit, or scheduled to be performed at a follow up visit. In this scenario, the recommendation of the 
telemedicine team will not be communicated to the participant since we do not yet know if a ‘no biopsy’ 
recommendation by the telemedicine team is a safe alternative to a ‘biopsy’ recommendation by the in-person 
dermatologist. 
 
Based on the outcomes described above, the participant will have either 1 visit and 1 phone call (initial evaluation and 
follow-up phone call), or an additional visit for telemedicine recommended biopsy and an additional phone call with biopsy 
results.  

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7.3.1 
Pre-Screening  
Pre-Screening Visit (no time frame prior to enrollment) 
• 
Participant reads general requirements for eligibility and calls to schedule an appointment at the DCSU if study 
requirements are met 
• 
During the scheduling phone call, study staff determine if the prospective participant meets eligibility criteria 
(Supplement O & P) 
• 
During the phone call, eligible participants have the option to view and discuss the consent form electronically. If 
they opt to do so, participants will be sent a consent form through RedCap, which they can view during the phone 
call and sign at any time prior to Visit 1. After signing the electronic consent form, participants also have the option 
to fill out the enrollment questionnaire electronically. 
7.3.2 
Enrollment/Baseline 
Enrollment/Initial Visit (Visit 1, Day 1) 
• 
Participant and lesion eligibility confirmed by study personnel 
o 
This is the formal study screening prior to official enrollment (i.e. signing informed consent) 
• 
Participant given Key Information Sheet with an overview of the study (Supplement Q) 
• 
Conduct informed consent procedure and obtain signed ICF, if not conducted electronically prior to visit 
• 
Assign subject ID for participant  
• 
Obtain demographic information, medical history, medication history as part of enrollment questionnaire 
(Supplement K). If not conducted electronically prior to visit 
• 
Acquire clinical images, dermoscopic image, and Nevisense data for each lesion 
o 
Nevisense procedure: the lesion is cleansed with an alcohol wipe and the electrical impedance 
measurement is conducted using a spring-loaded probe and disposable electrode measuring 5mm x 5mm. 
The measurement takes <1 minute and the electrical impedance score (EIS) will be recorded. Larger 
lesions may require a second measurement at another location within the lesion.  
o 
Record any adverse events from the procedure 
o 
Neither participants nor the in-person dermatologist will be aware of the score. 
• 
Study team will number the skin lesions using Devon Skin Marker to verify same lesion evaluated across all 
assessments including the in person dermatologist 
• 
Fill out questionnaire assessing telemedicine evaluation experience so far (Supplement L) 
• 
In-person dermatologist examination of lesion(s) using naked eye and dermoscopy 
• 
If a biopsy is recommended by the in-person dermatologist, participant will be offered a skin biopsy procedure or 
offered a second appointment within 1-2 weeks for the biopsy procedure  
o 
If a biopsy is performed, the participant is given at-home instructions for wound care (Supplement R) and 
the expected wait time for the biopsy results 
o 
Alternatively, the participant can choose to have the procedure done at another facility. The signed ICF 
includes permission for the study team to obtain those medical records 
o 
Follow-up care to the skin biopsy will proceed per standard clinical practice and includes result 
communication, wound care monitoring, suture removal if applicable and recommendations for follow-up 
care.  
• 
If a biopsy is not recommended by the in-person dermatologist, the participant is given the expected wait time for 
telemedicine recommendation phone call. 
7.3.3 
Intermediate Visits 
Phone Call: For Participants without a Skin Biopsy recommendation by the in-person dermatologist for at least 1 
lesion (Day 4+/-2)  
• 
Communicate telemedicine recommendation (Supplement M & N) 
o 
If a skin biopsy is recommended, schedule participant for another in-person visit at the DCSU for skin biopsy 
procedure. 
o 
Alternatively, the participant can choose to have the procedure done at another facility. The signed ICF 
includes permission for the study team to obtain those medical records 
o 
If a skin biopsy is not recommended, thank the subject for their participation 
• 
Administer the study completion questionnaire (Supplement L) 
 
Visit 2: For Participants in whom a skin biopsy was recommended by the telemedicine team (Day 7+/-2)  
• 
Perform skin biopsy  
• 
If a biopsy is performed, the participant is given at-home instructions for wound care (Supplement R) and the 
expected wait time for the biopsy results 

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• 
Follow-up care to the skin biopsy will proceed the same as standard clinical practice with Visits 4 and 5 
 
Phone Call For Participants with Skin Biopsy after Teledermatologist recommendation (Day 17+/-3)  
• 
Record adverse events as reported by participant  
• 
Communicate biopsy pathological report results and medical advice for next steps if needed or reassurance 
(Supplement S) 
• 
Ask about symptoms and signs of wound healing progression 
 
Optional Visit 3: Wound Check for biopsy site performed on Visit 2 (Day 21+/-3)  
• 
Check site of biopsy for healing and any AEs 
• 
Communicate medical advice for next steps if necessary. 
7.3.4 
Study Completion 
Once all lesions have been evaluated, all biopsy results have been communicated, and all wounds are healing well, 
participants will be given a study completion questionnaire (Supplement L) regarding his/her overall experience in the study. 
At this point, participation in the study is complete. 
7.3.5 
Withdrawal/Early Termination Visit 
Participants may withdraw at any time by contacting the DCSU staff via phone call or in-person. For participants who did 
not undergo a skin biopsy, no follow-up care is needed. Participants who underwent a skin biopsy will be offered a final visit 
to communicate biopsy results, and for a wound check or suture removal if needed. They will also receive a referral to the 
NYU Skin & Cancer clinic for follow up care if needed. Any adverse events will also be recorded.  
7.3.6 
Unscheduled Visit 
Participants may call and report a concern or adverse event at any time during the study duration. The most likely reason 
for an unscheduled visit would be related to poor wound healing. The DCSU staff will handle the questions and refer to one 
of the study physicians as needed. The participant may be asked to come to the DCSU in for an in-person evaluation and 
management. The most likely management outcome if wound infection is suspected would be providing antibiotic ointment 
to the participant. Unscheduled visits will be recorded in a separate field in the participant’s case record form.  
8 Assessment of Safety 
8.1 
Specification of Safety Parameters  
• 
Safety parameters are not included in primary or secondary endpoints 
• 
Safety parameters to be recorded include participant adverse reactions to the imaging with the Nevisense device, 
as well as any adverse events recorded during intermediate, unscheduled or final study visits as reported by 
participants 
• 
Any new onset symptoms, signs, illness or experience during the participant duration of the study will be recorded, 
quality of new onset signs, symptoms, illness or experience will be recorded 
8.1.1 
Definition of Adverse Events (AE) 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course 
of the study. Intercurrent illnesses or injuries should be regarded as adverse events. Abnormal results of diagnostic 
procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
8.1.2 
Definition of Serious Adverse Events (SAE) 
Serious Adverse Event 
Adverse events are classified as serious or non-serious. A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 

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• a congenital anomaly or birth defect 
• an important medical event 
that is caused by, or associated with, the study agent, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application). 
Important medical events are those that may not be immediately life threatening, but are clearly of major clinical significance. 
They may jeopardize the subject, and may require intervention to prevent one of the other serious outcomes noted above. 
For example, drug overdose or abuse, a seizure that did not result in in-patient hospitalization, or intensive treatment of 
bronchospasm in an emergency department would typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious adverse events.  
8.1.3 
Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency (i.e. not described in study-related documents such as the IRB-
approved protocol or ICF, the investigators brochure, etc.) 
• Related or possibly related to participation in the research (i.e. possibly related means there is a reasonable 
possibility that the incident experience, or outcome may have been caused by the procedures involved in the 
research) 
• Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, 
economic, or social harm). 
This definition could include an unanticipated adverse device effect on health or safety caused by, or associated with, a 
device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application). 
8.2 
Classification of an Adverse Event 
8.2.1 
Severity of Event 
For AEs not included in the protocol defined grading system, the following guidelines will be used to describe severity. 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities. 
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events 
may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other 
treatment. Severe events are usually potentially life-threatening or incapacitating. 
8.2.2 
Relationship to Study Agent 
The clinician’s assessment of an AE's relationship to study agent (device) is part of the documentation process, but it is not 
a factor in determining what is or is not reported in the study. If there is any doubt as to whether a clinical observation is an 
AE, the event should be reported. All AEs must have their relationship to study agent assessed. In a clinical trial, the study 
product must always be suspect. To help assess, the following guidelines are used. 
 
• Related – The AE is known to occur with the study agent, there is a reasonable possibility that the study agent 
caused the AE, or there is a temporal relationship between the study agent and event. Reasonable possibility means 
that there is evidence to suggest a causal relationship between the study agent and the AE. 
• Not Related – There is not a reasonable possibility that the administration of the study agent caused the event, 
there is no temporal relationship between the study agent and event onset, or an alternate etiology has been 
established. 
8.2.3 
Expectedness 
Principal Investigator Dr. David Polsky will be responsible for determining whether an AE is expected or unexpected. An AE 
will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study procedures. The expected AE’s for the Nevisense device have been described in FDA 
clearance documents. There are no expected AE’s for the clinical and dermoscopic imaging.  
 

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8.3 
Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits. All AEs including local 
and systemic reactions not meeting the criteria for SAEs will be captured on the appropriate visit note. Information to be 
collected includes event description, time of onset, clinician’s assessment of severity, relationship to study product 
(assessed only by those with the training and authority to make a diagnosis), and time of resolution/stabilization of the event. 
All AEs occurring while on study must be documented appropriately regardless of relationship. All AEs will be followed to 
adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as baseline and not 
reported as an AE. However, if the study participant’s condition deteriorates at any time during the study, it will be recorded 
as an AE. UPs will be recorded in the data collection system throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of 
severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is obtained until 7 (for 
non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the investigator will 
inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution 
or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the subject is lost to 
follow-up, or the adverse event is otherwise explained. At the last scheduled visit, the investigator should instruct each 
subject to report any subsequent event(s) that the subject, or the subject’s personal physician, believes might reasonably 
be related to participation in this study.  
8.4 
Reporting Procedures – Notifying the IRB  
8.4.1 
Adverse Event Reporting 
AEs will be documented in the visit note including an event description, time of onset, clinician’s assessment of severity, 
relationship to study product (assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. AEs occurring with 7 days from end of participant study duration. The study staff that 
are responsible for completing AE reports are study administrators that first hear the participant report the event. The study 
staff that are responsible for signing off on AE reports include the principal investigator and/or study administrators recorded 
in key roles in the investigational protocol. All study administrators in key roles and the principal investigator will receive 
notification of all AEs. AEs are reportable to the IRB within 5 calendar days if the event or new information is consistent with 
the following: 
 
• 
new information indicating a change to the risks or potential benefits of the research, in terms of severity or 
frequency (such as analysis indicating more severe or frequent side effect or an FDA labeling change or withdrawal 
from market) 
• 
protocol deviation or violation, only if one or more of the following criteria is met: 
1. it was intended to eliminate apparent immediate hazard to a research participant 
2. it was harmful (caused harm to participants or others or placed them at increased risk of harm) 
3. it represented possibly serious or continued noncompliance 
• 
a complaint unresolved by the research team or that indicates increased or unexpected risks 
• 
incarceration of a participant, when the principal investigator believes it is in the best interest of the participant to 
remain in the study 
• 
an unanticipated adverse device effect 
• 
new information about the effect on health or safety or any life-threatening problem or death caused by or associated 
with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence 
 

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8.4.2 
Serious Adverse Event Reporting 
SAEs will be documented in the visit note including an event description, time of onset, clinician’s assessment of severity, 
relationship to study product (assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. SAEs occurring with 30 days from end of participant study duration. The study staff that 
are responsible for completing SAE reports are study administrators that first hear the participant report the event. The study 
staff that are responsible for signing off on SAE reports include the principal investigator and/or study administrators 
recorded in key roles in the investigational protocol. All study administrators in key roles and the principal investigator will 
receive notification of all SAEs. SAEs are reportable to the IRB within 5 calendar days if the event or new information is 
consistent with the following: 
 
• 
new information indicating a change to the risks or potential benefits of the research, in terms of severity or 
frequency (such as analysis indicating more severe or frequent side effect or an FDA labeling change or withdrawal 
from market) 
• 
protocol deviation or violation, only if one or more of the following criteria is met: 
1. it was intended to eliminate apparent immediate hazard to a research participant 
2. it was harmful (caused harm to participants or others or placed them at increased risk of harm) 
3. it represented possibly serious or continued noncompliance 
• 
a complaint unresolved by the research team or that indicates increased or unexpected risks 
• 
incarceration of a participant, when the principal investigator believes it is in the best interest of the participant to 
remain in the study 
• 
an unanticipated adverse device effect 
• 
new information about the effect on health or safety or any life-threatening problem or death caused by or associated 
with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence 
 

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8.4.3 
Unanticipated Problem Reporting 
Incidents or events that meet the criteria for UPs indicated in section 8.1.3 require the creation and completion of an UP 
report form. It is the site investigator’s responsibility to report UPs to their IRB. The UP report will include the following 
information: 
 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• A detailed description of the event, incident, experience, or outcome; 
• An explanation of the basis for determining that the event, incident, experience, or outcome represents an UP; 
• A description of any changes to the protocol or other corrective actions that have been taken or are proposed in 
response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
• UPs will be reported to the IRB within 5 calendar days of the investigator becoming aware of the event. 
 

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8.5 
Study Halting Rules 
The study will be halted when three grade 3 AEs determined to be “related” are reported to the IRB.  
8.6 
Safety Oversight 
 
Safety oversight will be under the direction of an appointed Medical Monitor (MM), a medical expert that advises the study 
investigators and monitors participant safety. The role of the Medical Monitor is to 1) Review all AEs on a regular basis 
throughout the trial; 2) Be available to advise the investigators on trial-related medical questions or problems, and 3) 
Evaluate cumulative participant safety data and make recommendations regarding the safe continuation of the study. The 
Medical Monitor is Dr. Shirin Bajaj. Dr. Shirin Bajaj is a Clinical Instructor in the Ronald O. Perelman Department of 
Dermatology.,. She is actively conducting clinical research on the use of lasers in dermatology,. She is well-qualified to 
serve as the Medical Monitor for this study.  
9 Clinical Monitoring 
Clinical site monitoring will be conducted to ensure that the rights and well-being of human subjects are protected, that the 
reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently 
approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). 
 
• Site Investigators, , Adriana Lopez, Duy Tran, Efe Kakpovbia and Vignesh Ramachandran will conduct the 
monitoring activities and report to the medical monitor Dr. Shirin Bajaj. These doctors are PGY-3 and PGY-4 
dermatology residents, and are not members of the telemedicine team.  
• Dr. Polsky (study PI) is a member of the telemedicine team and needs to remain blinded to the data until the study 
conclusion, so he cannot conduct the clinical monitoring. The monitoring team will report their monthly findings to 
Dr. Polsky while maintaining blinding of specific participant identifiable details. 
• The monitoring will consist of monthly reviews of all the CRFs and the image database to ensure that all records are 
complete (i.e. no missing data). They will review the frequency and nature of any adverse events and participant 
withdrawals from the study. They will also review the screening and enrollment data to insure that eligible participants 
are not being incorrectly excluded from the study, and that ineligible participants are being appropriately excluded. 

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10 Statistical Considerations  
10.1 Statistical Hypotheses 
Primary endpoint:  
We will not perform hypothesis testing in this pilot study; we will use descriptive statistics and summarize preliminary 
evidence from this pilot study. 
 
Secondary endpoints 
We will not perform hypothesis testing in this pilot study. 
10.2 Analysis Datasets 
All eligible lesions evaluated by both the teledermatologists and the in-person dermatologist. 
10.3 Description of Statistical Methods 
10.3.1 General Approach 
The general approach will be to determine the agreement between in-person recommendation and the telemedicine (tele) 
recommendation. For this reason the data will be categorical in nature and the specific measures to be assessed are 
described below. We will also examine the performance characteristics of the tele approach (e.g. sensitivity, specificity, etc.) 
using the in-person dermatologist biopsy decision as the ‘gold standard’(primary endpoint). However, it is possible that with 
respect to the pathology results (secondary endpoint), the tele approach may have a higher sensitivity and specificity to 
diagnose skin cancer than the in-person dermatologist. For this reason, we will also examine the performance of the tele 
and in-person biopsy decisions against the pathology results as the ‘gold standard’.  
10.3.2 Analysis of the Primary Efficacy Endpoint(s) 
To determine the agreement between in-person recommendation and the telemedicine (tele) recommendation we can 
calculate the number of discordant benign vs. malignant diagnoses; specifically, the number of subjects that were 
recommended a biopsy from the in-person dermatologist but were recommended no biopsy from the teledermatology team, 
and the number of subjects that were recommended no biopsy from the in-person dermatologist but biopsy by the 
teledermatologist team. We can calculate the Kappa coefficient as a measure of the degree of concordance or agreement 
with confidence intervals. We can also calculate “sensitivity” and “specificity” of the tele method assuming in-person 
diagnosis as the gold standard. Similarly, we can separately evaluate the agreement between in-person and: 1) dermoscopy 
alone; and 2) Nevisense (EIS score >4) without dermoscopy. We will also estimate the improvement (if any) of using both 
methods compared to one method. We expect the Kappa coefficient to be close to one, and high “sensitivity” and “specificity” 
(close to 1) for the SpotCheck method assuming in-person diagnosis as the gold standard. 
10.3.3 Analysis of the Secondary Endpoint(s) 
Secondary endpoint (1) will be a descriptive analysis of Sensitivity, Specificity, Positive Predictive Value, and Negative 
Predictive Value, using the histopathology results as the gold standard. We will assess potential difference or advantages 
in terms of: a) enhanced telemedicine diagnostic system; b) telemedicine Nevisense alone; c) telemedicine clinical + 
dermoscopy alone; and d) in-person dermatologist diagnosis. Sensitivity, Specificity, Positive Predictive Value, and 
Negative Predictive Value will be reported with an upper and lower confidence interval. Lesions with missing data will not 
be included in the relevant analyses (see Study Design schematic footnote 3). Participants lost to follow-up for reporting 
his/her biopsy results will be included in the analysis as the data required for analysis has been collected.  
 
As another secondary endpoint, we will be evaluating the enhanced telemedicine service’s impact on patient centered 
outcomes. Descriptive statistics for this secondary endpoint (2) (patient questionnaires, Supplement L will be presented as 
percentages. Study completion questionnaires may be qualitatively analyzed for themes and quantified by thematic 
representation across participants. Participant agreement of thematic categories will be calculated as percentages as a 
summary measure. Factors for stratification may include participants with a biopsy procedure and those without biopsy 
procedure as well as diagnosis of malignancy or benign lesion within those with biopsy. Participants with missing study 
completion questionnaire results due to inadequate duration of phone call will not be included.  
 
As a final secondary endpoint (3), we will estimate the number of lesions that may benefit from the additional information of 
the Nevisense score to the clinical and dermoscopic exam. This estimation will be provided by the in-person dermatologist, 
and separately by each of the three teledermatologists (Supplement T & U). The estimates will be expressed as 
percentages. Any lesion with missing data in the in-person dermatologist and teledermatologist plan will not be included in 
analysis. Participants lost to follow-up will still be included in analysis of this endpoint as required data for this endpoint 
determination has been captured in the first visit.  

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10.3.4 Safety Analyses 
Safety events will be coded in a medical dictionary for similar presentations of symptoms, signs, illness, or experience. Each 
AE will be counted once for a given participant and will be presented with severity, frequency, and relationship to the 
diagnostic method. The outcome and duration of each AE will also be presented. AE will be ascertained as those that are 
reported to the study team at the relevant visit. All AEs leading to premature termination or withdrawal from study and all 
SAEs will be presented in a table.  
10.3.5 Adherence and Retention Analyses 
Adherence is not applicable. Participation is defined as all subjects that enroll into the study. Study retention is defined as 
participants that complete all visits through the last visit (study completion questionnaire) out of the number of subjects 
enrolled. Participants lost to follow up include all those that were unable to be contacted for biopsy scheduling, wound check, 
or study completion questionnaire administration.  
10.3.6 Baseline Descriptive Statistics 
Baseline characteristics used for baseline descriptive statistics include demographic information, past medical history of 
skin cancer, family history of skin cancer, natural hair color, eye color, tanning bed exposure, moderate to severe sunburn 
exposure, history of atypical or dysplastic nevi, estimate of number of moles on body, and estimate of number of freckles 
on face. Inferential statistics will not be used. 
10.3.7 Planned Interim Analysis 
Not applicable 
10.3.7.1 Safety Review 
Not applicable 
10.3.7.2 Efficacy Review 
Not applicable 
10.3.8 Additional Sub-Group Analyses 
Primary endpoint and secondary endpoints will be analyzed by age, sex, and race/ethnicity.  
10.3.9 Multiple Comparison/Multiplicity 
Not applicable 
10.3.10 Tabulation of Individual Response Data 
Not applicable 
10.3.11 Exploratory Analyses 
Exploratory analysis may be conducted using the continuous Nevisense score or categorical unequivocally benign lesion 
designation (using clinical and dermoscopic image alone) as factors of stratification before re-evaluation of primary endpoint 
again. 
10.4 Sample Size 
Number of subjects to recruit and screen is estimated to be 650 or fewer. Number of participants eligible is estimated to be 
500 or fewer. Based on the previously mentioned Norwegian study, we anticipate a biopsy recommendation rate of 10% 
between the telemedicine and in-person evaluations. With each participant presenting with 1-3 lesions, an estimate of 1000 
evaluated lesions (2 per participant on average) is possible. Assuming a biopsy recommendation 10% from this historical 
data, there will be likely 50 - 100 biopsies recommended and 450 - 900 lesions not recommended for biopsy.9 
 
We anticipate 2% of the sample will be lost to follow up based on historical data. Missing data is estimated at 4% based on 
those lost to follow up and technical error based on historical data.11 We anticipate 1% of participants to withdraw based on 
historical data.12 Participants who have formally withdrawn from the study will not be included in primary or secondary 
endpoint analysis, nor will they be included in the analysis datasets.  

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10.5 Measures to Minimize Bias 
10.5.1 Enrollment/Randomization/Masking Procedures 
10.5.2 Subjects will be self-enrolled into the study by viewing an advertisement and making an appointment for 
enrollment at the DCSU. Enrollment procedures include eligibility verification and informed consent confirmation 
with signature. The in-person dermatologist (control arm) and telemedicine team (intervention arm) will each be 
blinded to the other’s management recommendation. The in-person dermatologist will be blinded to the Nevisense 
score. Additionally, the teledermatologist team of 3 physicians will be masked to each other’s management plan. 
If one teledermatologist is absent (due to vacation, illness etc.) and cannot make their recommendations, a 
minimum of 2 teledermatologists is satisfactory to make a consensus. If any teledermatologist recommends 
biopsy, the team recommendation will be biopsy. Periodic reviews of teledermatology diagnoses by the 
teledermatology team will be held in order to improve quality control during the study. Evaluation of Success of 
Blinding 
Not applicable 
10.5.3 Breaking the Study Blind/Participant Code 
Breaking the study blind for all participants may occur in the event of an SAE. Both intentional and unintentional breaking 
of the blind will be reported to the principal investigator.  
11 Source Documents and Access to Source Data/Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical trial necessary 
for the reconstruction and evaluation of the trial. Source data are contained in source documents. For this study source 
documents will include case record forms (CRFs), clinical and dermoscopic images, patient questionnaires, in-person and 
teledermatologist data collection forms, and pathology reports. All data collected using paper documentation will be 
transferred to an electronic CRF maintained in REDCap. Paper copies for auditing purposes will be kept in a locked file 
cabinet in a locked office in the Dermatology Department. Images will be maintained on a NYULH computer server in a 
Department of Dermatology dedicated folder or in Epic.  
 
The study case report form (CRF) is the primary data collection instrument for the study. All data requested on the CRF 
must be recorded. All missing data must be explained. If a space on the CRF is left blank because the procedure was not 
done or the question was not asked, write “N/D”. If the item is not applicable to the individual case, write “N/A”. All entries 
should be printed legibly in black ink. If any entry error has been made, to correct such an error, draw a single straight line 
through the incorrect entry and enter the correct data above it. All such changes must be initialed and dated. DO NOT 
ERASE OR WHITE OUT ERRORS. For clarification of illegible or uncertain entries, print the clarification above the item, 
then initial and date it. 
12 Quality Assurance and Quality Control 
QA procedures include a study staff member at the DCSU verifying the exact lesion(s) of concern with the participant after 
the participant completes the enrollment questionnaire. DCSU study staff will double check the enrollment questionnaire for 
all missing information and ensure answers are filled out before the participant proceeds to the next step. All acquired 
images will be assessed for quality prior to acceptance and progression to Nevisense data acquisition. Study personnel will 
double check the Nevisense score prior to recording into the patient CRF.  
 
QC procedures will be implemented beginning with the data entry system and an initial data QC check that will be run on 
the database once it is generated. Any missing data or data anomalies will be communicated to the site for 
clarification/resolution. 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, documented 
(recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirements (e.g., Good 
Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 
The investigational site will provide direct access of source data/documents, and reports for the purpose of inspection by 
local and regulatory authorities. 

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13 Ethics/Protection of Human Subjects 
13.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection of Human 
Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or the ICH E6. 
13.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for 
review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. 
Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the 
study. All changes to the consent form will be IRB approved; a determination will be made regarding whether previously 
consented participants need to be re-consented. 
13.2.1 Telephone Pre-Screen: 
This study will have 2 consent processes: The first is the research team will speak with interested participants over the 
telephone and ask for verbal consent before asking some eligibility criteria-related questions.  
 
Advertisements will list, and interested participants will be given the DCSU phone number to reach if they are interested in 
participating in the study. A phone pre-screen process with potential interested subjects will take place by phone when the 
participant calls the DCSU. The research team will ask for verbal consent prior to asking the pre-screen questions to 
determine if a potential participant is eligible to enroll in the study. The questions are in regards to the eligibility criteria which 
consist of age, pregnancy status, lesion location and history of prior biopsy of the lesion. If the individual is eligible for the 
study then they will be scheduled for a screening visit. If they are not eligible or decide not to participate, any information 
collected will be immediately destroyed. Informed Consent Process 
13.2.2 Consent/Assent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study procedures and risks are given to the participant and written documentation of 
informed consent is required prior to starting the intervention.  
13.2.3 Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study and continues 
throughout the individual’s study participation. Extensive discussion of risks and possible benefits of participation will be 
provided to the participants and their families. Consent forms will be IRB-approved and the participant will be asked to read 
and review the document. In a private room at the DCSU, the investigator will explain the research study to the participant 
and answer any questions that may arise. All participants will receive a verbal explanation in terms suited to their 
comprehension of the purposes, procedures, and potential risks of the study and of their rights as research participants. 
Participants will have the opportunity to carefully review the written consent form and ask questions prior to signing. The 
participants should have the opportunity to discuss the study with their surrogates or think about it prior to agreeing to 
participate. The participant will sign the informed consent document on the day of the consent discussion prior to any 
procedures being done specifically for the study. Alternatively, the participant may view and sign the consent form remotely 
through an electronic informed consent (e-consent) process prior to taking part in any study procedures. For the e-consent 
process, the discussion of consent will be conducted via phone after the telephone pre-screen. The participant will then 
receive a RedCap link to review and sign the electronic consent form. The RedCap consent document will include the same 
information contained within the paper informed consent document. In signing the consent form, subjects agree to 
comprehension of the nature of the study. The participants may withdraw consent at any time throughout the course of the 
trial. A copy of the signed informed consent document will be given to the participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their medical care will not be adversely 
affected if they decline to participate in this study. 
 
A copy of the signed informed consent document will be stored in the subject’s research record. The consent process, 
including the name of the individual obtaining consent, will be thoroughly documented in the subject’s research record. Any 
alteration to the standard consent process (e.g. use of a translator, consent from a legally authorized representative, consent 
document presented orally, etc.) and the justification for such alteration will likewise be documented. A sample informed 
consent form is provided in the appendix of the protocol.  
 
Capacity will be assessed if a subject is able to reiterate the risks and benefits of the study, articulate their decision and the 
rationale for his or her decision. Persons with diminished capacity are allowed to participate in the study as it is of minimal 
risk and offers the direct benefit of free cancer screening. Decisionally impaired adults will be asked to verbally state their 
decision and rationale to ensure comprehension during assent.  

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13.3 Participant and Data Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require a signed subject authorization 
informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the ability to 
use all information collected prior to the revocation of subject authorization. For subjects that have revoked authorization to 
collect or use PHI, attempts should be made to obtain permission to collect at least vital status (i.e. that the subject is alive) 
at the end of their scheduled study period. 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and their agents. This 
confidentiality is extended to cover testing of biological samples in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be held in strict confidence.  
 
Any clinical images captured using Epic Haiku or the study specific camera and include identifiable features (faces, full body 
images, tattoos, etc) will be  stored directly in the patient’s medical record as research note. The teledermatology team will 
have access to the patient’s chart via an NYU EPIC MRN. Clinical images will not be stored on the device itself or any other 
platform. Identifiable images of participants will not be captured or stored in the DermLite Cam due to the standardized, 
constrained distance for clinical images required by this device.  
 
Any clinical images captured using the Demetra that include identifiable features (faces, full body images, tattoos, etc) will 
be securely stored in the Demetra Cloud. The teledermatology team will have access to the patient’s record via secure login 
access using username and password. Images are also stored on the Demetra device, which requires a user specific four-
digit PIN code for operation. 
 
The study monitor, representatives of the IRB or pharmaceutical company supplying study product may inspect all 
documents and records required to be maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site will permit access to such 
records. 
 
The study participant’s contact information will be securely stored at the clinical site for internal use during the study. At the 
end of the study, all records will continue to be kept in a secure location for as long a period as dictated by local IRB and 
Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to 
and stored at NYU Langone Medical Center. This will not include the participant’s contact or identifying information. Rather, 
individual participants and their research data will be identified by a unique study identification number. The study data entry 
and study management systems used by clinical sites and by NYU Langone Medical Center research staff will be secured 
and password protected. At the end of the study, all study databases will be de-identified and archived at the NYU Langone 
Medical Center. 
13.3.1 Research Use of Stored Human Samples, Specimens, or Data 
There will not be storage of biological samples. 
• Intended Use: Clinical and dermoscopic images, and Nevisense data may be used to study benign dermatological 
diagnoses and melanoma. No genetic testing will be performed. 
• Storage: Access to the data (stored online) will be limited by password protection.  
• Data will be kept in password-protected computers. Only investigators will have access to the samples and data.  
• Tracking: not applicable.  
• Disposition at the completion of the study: data described above will be maintained indefinitely. Study participants 
who request destruction of their data will be notified of compliance with such request and all supporting details will 
be maintained for tracking. 
13.4 Future Use of Stored Specimens 
Biological samples will not be obtained from the pathology laboratory and will not be used for future studies. Deidentified 
clinical and dermoscopic images may be used for future studies. Within the Informed Consent form, there is an optional 

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yes/no checkbox and place for an initial signature to provide this permission. These images could be used for research into 
the diagnosis of skin cancer and other conditions for which individuals with skin lesions are at increased risk, and to improve 
early detection. Any future studies with these images will be managed by the NYU IRB, just as this study is. One purpose 
of future studies would be to augment the strength of artificial intelligence diagnostics with a higher volume of images, 
particularly of the benign lesion category which currently is limited.  
 
During the conduct of the study, an individual participant can choose to withdraw consent to have images stored for future 
research.  
 
When the study is completed, access to study data and/or images will be provided through the DCSU. 
14 Data Handling and Record Keeping 
14.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. The investigator 
is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data. Black ink is 
required to ensure clarity of reproduced copies. When making changes or corrections, cross out the original entry with a 
single line, and initial and date the change. DO NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON 
THE ORIGINAL. Time for submission of CRFs are within 48 hours of the visit. Paper source documents will be housed 
centrally at the DCSU.  
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for recording data for 
each participant enrolled in the study. Data reported in the eCRF derived from paper source documents should be consistent 
with the paper source documents or the discrepancies should be explained and captured in a progress note and maintained 
in the participant’s official electronic study record. 
 
Clinical data (including AEs, prior or concomitant medications, and expected adverse reactions data) and clinical laboratory 
data will be entered into REDCap, a 21 CFR Part 11-compliant data capture system provided by NYULMC. The data system 
includes password protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
Study staff at the DCSU will collect data as well as review data, trial materials, and reports. The study team will conduct 
interpretation of data, plans for analysis, review of tables and listings, and plans for reporting at locations within the NYU 
Department of Dermatology (e.g. office of the PI, conference rooms, etc.). After the study is completed, the de-identified, 
archived data will be stored in a dedicated folder in the NYU Department of Dermatology server allocation under the 
supervision of David Polsky (PI), for use by other researchers once relevant approvals are in place. 
14.2 Study Records Retention 
Study documents will be retained for a minimum of 3 years after close-out or 5 years after final reporting/publication. 
However, images and associated meta-data will be retained indefinitely for potential use in future studies. 
14.3 ClinicalSafety Monitoring: 
Shirin Bajaj, MD is responsible for overall clinical safety monitoring. As noted in Section 8.6, Dr. Bajaj is a Clinical Instructor 
in the Ronald O. Perelman Department of Dermatology. She is well qualified to serve as the Medical Monitor for this study.  
Clinical safety monitoring will consist of reviewing monthly summarized data of all the REDCAP CRFs, put together by the 
study’s research coordinator or research associate. Research coordinator/associate will include a MoleCam software report 
AND/OR Demetra software report with images and locations for each lesion, and research coordinator/associate will confirm 
that all records have no missing data The clinical safety monitoring report will also include frequency and nature of any 
adverse events, participant withdrawals, screen failures, number of enrolled participants, diagnoses, protocol deviations 
and the benign/malignant ratio. The literature suggests the typical benign: malignant ratio is about 29:1.13-16 The definition 
of non-inferior in the clinical trial setting is most often defined as within 50% unidirectionally from the endpoint of the control.17 
In this case, a growth by 50% in this ratio becomes 44:1. Study stopping criteria will be when the teledermatology team 
reaches a benign: malignant ratio of 44:1, which will be a signal of unacceptably high added risk to the patient due to 
unnecessary skin biopsy procedure. If the Clinical Safety Monitor identifies a melanoma that was missed by the 
teledermatology team, and identified by the in person dermatologist, the Monitor will notify the PI and they will review the 
case. The clinical safety monitor will ensure all unanticipated problems involving risks to subjects or others are appropriately 
handled; interim safety reviews are performed; and the procedures for transmitting the results to the IRB are followed. 

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14.4 Data Integrity Monitoring: 
The data safety team, comprised of the study coordinator and study associate will review all source documents and 
REDCAP database for accuracy and completeness. They will also review the screening and enrollment data to ensure that 
eligible participants are not being incorrectly excluded from the study, and that ineligible participants are being appropriately 
excluded. The data safety team will run monthly reports and confirm on the monthly review reports to the clinical safety 
monitor that all data in the REDCAP database and the CRFs are complete and accurate. 
 
A monthly report will be prepared indicating the numbers of adverse events, subject complaints, numbers of subjects 
enrolled, numbers of screen failures, recommendations for continuing the study, and any protocol deviations.  
14.5 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
 
These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report deviations within 5 working 
days of identification of the protocol deviation, or within 5 working days of the scheduled protocol-required activity. 
 
All protocol deviations must be addressed in study source documents. Protocol deviations must be reported to the local IRB 
per their guidelines. The site PI/study staff is responsible for knowing and adhering to their IRB requirements. Further details 
about the handling of protocol deviations will be included in the MOP. 
14.6 Publication and Data Sharing Policy 
All who occupy key roles for the study are eligible for authorship in study publications. The International Committee of 
Medical Journal Editors (ICMJE) member journals have adopted a clinical trials registration policy as a condition for 
publication. The ICMJE defines a clinical trial as any research project that prospectively assigns human subjects to 
intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical 
intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral 
treatments, process-of-care changes, and the like. Health outcomes include any biomedical or health-related measures 
obtained in participants, including pharmacokinetic measures and adverse events. The ICMJE policy, and the Section 801 
of the Food and Drug Administration Amendments Act of 2007, requires that all clinical trials be registered in a public trials 
registry such as ClinicalTrials.gov, which is sponsored by the National Library of Medicine. Other biomedical journals are 
considering adopting similar policies. For interventional clinical trials performed under NIH IC grants and cooperative 
agreements, it is the grantee’s responsibility to register the trial in an acceptable registry, so the research results may be 
considered for publication in ICMJE member journals. The ICMJE does not review specific studies to determine whether 
registration is necessary; instead, the committee recommends that researchers who have questions about the need to 
register err on the side of registration or consult the editorial office of the journal in which they wish to publish. 
15 Study Finances 
15.1 Funding Source 
The study will be financed through foundation grants and philanthropic funds available to the study PI. To date, the 
Melanoma Research Alliance and the Sergei S. Zlinkoff Fund for Medical Education have provided partial funding the study, 
and other foundation grant applications have been submitted. 
15.2 Costs to the Participant 
There is no cost to subjects for any study procedures including the in-person dermatologist, teledermatology evaluation or 
possible skin biopsy (if performed at our DCSU). If subjects are found to have a skin cancer, treatment of the skin cancer 
will not be covered by the study and any further cost for treatment will be incurred by the subject and their insurance 

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15.3 Participant Reimbursements or Payments 
Participants will be compensated $25 for participating in the first visit of the study. If the participant qualifies for additional 
visits, he or she will be paid up to an additional $50 ($25 for each recommended return visit). Compensation will be provided 
in the form of a check that will be mailed to the mailing address provided to us. If the participant chooses to leave or withdraw 
from the study for any reason before finishing the entire study (including if he or she does not follow through with 
recommendations to biopsy a concerning skin spot(s) identified during the study and/or does not share with us results from 
skin biopsy(s) performed by outside providers of concerning skin spot(s) identified during the study), he or she will not 
receive the compensation to which they were entitled based on the above scheme for prorated payments. 
 
16 Study Administration 
16.1 Study Leadership 
Not applicable 
17 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the device manufacturer, is critical. 
Therefore, any actual conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any 
aspect of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest will be 
required to have such conflicts managed in a way that is appropriate to their participation in the trial.  
 
All NYULMC investigators will follow the applicable conflict of interest policies. 
18 References 
1. Gershenwald JE, Scolyer RA, Hess KR, Sondak VK, Long GV, Ross MI, Lazar AJ, Faries MB, Kirkwood JM, McArthur 
GA, Haydu LE, Eggermont AMM, Flaherty KT, Balch CM, Thompson JF, for members of the American Joint Committee on 
Cancer Melanoma Expert P, the International Melanoma D, Discovery P. Melanoma staging: Evidence-based changes in 
the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67(6):472-92. doi: 
10.3322/caac.21409. PubMed PMID: 29028110. 
2. Buja A, Sartor G, Scioni M, Vecchiato A, Bolzan M, Rebba V, Sileni VC, Palozzo AC, Montesco M, Del Fiore P, Baldo V, 
Rossi CR. Estimation of Direct Melanoma-related Costs by Disease Stage and by Phase of Diagnosis and Treatment 
According to Clinical Guidelines. Acta Derm Venereol. 2018;98(2):218-24. Epub 2017/11/08. doi: 10.2340/00015555-2830. 
PubMed PMID: 29110018. 
3. Harvey, Valerie M., et al. "Social determinants of racial and ethnic disparities in cutaneous melanoma outcomes." Cancer 
Control 21.4 (2014): 343-349. 
4. Carli, P., et al. "Improvement of malignant/benign ratio in excised melanocytic lesions in the ‘dermoscopy era’: a 
retrospective study 1997–2001." British Journal of Dermatology 150.4 (2004): 687-692. 
5. Chuchu, Naomi, et al. "Teledermatology for diagnosing skin cancer in adults." Cochrane Database of Systematic 
Reviews12 (2018). 
6. Terushkin, Vitaly, et al. "Analysis of the benign to malignant ratio of lesions biopsied by a general dermatologist before 
and after the adoption of dermoscopy." Archives of dermatology146.3 (2010): 343-344. 
7. 
Nevisense 
Premarket 
Approval 
(PMA): 
U.S. 
Food 
and 
Drug 
Administration; 
2017. 
Available 
from: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=320650. 
8. 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;171(5):1099-107. Epub 
2014/05/21. doi: 10.1111/bjd.13121. PubMed PMID: 24841846; PMCID: Pmc4257502. 
9. Kjome RLS, Wright DJ, Bjaaen AB, Garstad KW, Valeur M. Dermatological cancer screening: Evaluation of a new 
community 
pharmacy 
service. 
Res 
Social 
Adm 
Pharm. 
2017;13(6):1214-7. 
Epub 
2016/12/15. 
doi: 
10.1016/j.sapharm.2016.12.001. PubMed PMID: 27964893. 
10. Svoboda, Ryan M., Abigail I. Franco, and Darrell S. Rigel. "Electrical Impedance Spectroscopy Versus Clinical 
Inspection Approaches: Melanoma Efficacy Detection Comparison." SKIN The Journal of Cutaneous Medicine 2.3 (2018): 
162-167. 
11. Rocha, L., et al. "Analysis of an electrical impedance spectroscopy system in short‐term digital dermoscopy imaging of 
melanocytic lesions." British Journal of Dermatology 177.5 (2017): 1432-1438. 
12. Marks JG, Miller JJ. 9 - Scaling Papules, Plaques, and Patches. In: Marks JG, Miller JJ, eds. Lookingbill and Marks' 
Principles of Dermatology (Sixth Edition). London: Content Repository Only!; 2019:113-134. 

Study number: s19-01242   
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13. Bowns, Ian R., et al. "Telemedicine in dermatology: a randomised controlled trial." Health Technology Assessment 
(Winchester, England) 10.43 (2006): iii-iv. 
14. 
Carli P, De Giorgi V, Crocetti E, et al. Improvement of malignant/benign ratio in excised melanocytic lesions in the 
'dermoscopy era': a retrospective study 1997-2001. Br J Dermatol 2004;150:687-92. 
15. 
Argenziano G, Cerroni L, Zalaudek I, et al. Accuracy in melanoma detection: a 10-year multicenter survey. J Am 
Acad Dermatol 2012;67:54-9. 
16. 
English DR, Del Mar C, Burton RC. Factors influencing the number needed to excise: excision rates of pigmented 
lesions by general practitioners. Med J Aust 2004;180:16-9. 
17. 
Hansen C, Wilkinson D, Hansen M, Argenziano G. How good are skin cancer clinics at melanoma detection? 
Number needed to treat variability across a national clinic group in Australia. J Am Acad Dermatol 2009;61:599-604. 
18. Althunian TA, de Boer A, Groenwold RHH, Klungel OH. Defining the noninferiority margin and analysing 
noninferiority: An overview. Br J Clin Pharmacol. 2017;83(8):1636–1642. doi:10.1111/bcp.13280 
 
 
 
 

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19 Supplemental Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol. They are stored and modified 
separately. As such, modifications to these documents do not require protocol amendments 
 
A. Nevisense Summary of Safety and Effectiveness (PMA) 
B. Nevisense Administration & Service Instructions 
C. Nevisense Instructions for Use 
D. Study Print Advertisement 
E. Study Online Advertisement 
F. Sample Certified Letter For Malignancy Diagnosis 
G. Sample Certified Letter For Skin Biopsy Recommendation 
H. Emergency Patient Card (samples) 
I. 
Nevisense Acquisition Commitment Letter from SciBase 
J. DermLite Cam Instructions for Use 
K. Enrollment Patient Questionnaire 
L. Participant Experience Questionnaires (After data acquisition, Visit 1, Visit 3)  
M. Teledermatologist Biopsy Recommendation Phone Script 
N. Teledermatologist No Biopsy Recommendation Phone Script 
O. Pre-screening Questionnaire  
P. Pre-screening and Scheduling Phone Script 
Q. Key Information Sheet (for participant) 
R. Wound Care (take-home patient sheet) 
S. Wound Care Assessment & Biopsy Result Communication Phone Script 
T. In-Person Dermatologist Data Collection Form  
U. Teledermatologist Data Collection Form 

Study number: s19-01242  
 
Page 31 
Version: May 16, 2022 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center. Do not disclose or use except as authorized in writing by the study sponsor 
Interventional Template Version: 05 JAN 2017 
 
20 Schedule of Events 
 
 
Activity 
Pre-Screening 
Visit 
 
First Visit 
[1] 
Teledermatologist 
Report Phone 
Call* 
[4+/-2] 
Skin Biopsy 
Visit* 
[7 +/-2] 
Biopsy Pathology 
Result Phone 
Call* 
[17 +/- 3] 
Suture Removal 
Visit* 
[21+/- 3] 
Study team procedures 
 
  
 
  
 
  
Recruitment Survey and possible scheduling for 
first visit 
X 
 
 
 
 
 
Eligibility Screening 
 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
Enrollment Questionnaire with Medical History 
 
X 
 
 
 
 
Physical Exam 
 
X 
 
 
 
 
Procedural Intervention (Image acquisition, 
Nevisense measurement) 
 
X 
 
 
 
 
Control Intervention (in-person dermatologist 
evaluation) 
 
X 
 
 
 
 
Skin biopsy procedure 
 
X* 
 
X* 
 
 
Teledermatologist report communicated  
 
 
X* 
 
 
 
Scheduled for biopsy  
 
 
X* 
 
 
 
Wound Check  
 
 
 
 
X* 
X* 
Suture removal (if necessary) 
 
 
 
 
 
X* 
Communicate Biopsy result 
 
 
 
 
X* 
 
Scheduled for suture removal (if necessary) 
 
 
 
X* 
X* 
 
Subject Study Completion Questionnaire 
 
 
X* 
 
X* 
 
Laboratory Assessments 
 
 
 
 
 
 
Skin Biopsy Processing Initiated 
 
X* 
 
X* 
 
 
 
*For Select Participants