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Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

NCT03315286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2019-12-18

Study results available
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Summary

This study will evaluate the safety and effectiveness of Shade for the management of UV-induced skin complications and data collected from this study will be used to support the proposed indications for use.

Conditions

  • Skin Cancer
  • Actinic Keratoses
  • Ultraviolet-Induced Change in Normal Skin
  • Behavior, Health
  • Behavior, Risk Reduction

Interventions

DEVICE

SHADE Ultraviolet Sensor

Patients will wear device for 6 months in addition to their own method of photo-protection.

BEHAVIORAL

Standard of care counseling

Patients will use their own method of photo-protection

Sponsors & Collaborators

  • YouV Labs Inc.

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • George Varghese, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2019-01-31
Completion
2019-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315286 on ClinicalTrials.gov