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Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL

NCT05755139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-22

No results posted yet for this study

Summary

Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the treatment. Skin and lesion attributes will be examined by the SMART system and the physician

Conditions

  • Vascular Lesion
  • Pigmented Lesions

Interventions

DEVICE

IPL with smart diagnostic handpiece

treatment with IPL following diagnostic with SMART system

Sponsors & Collaborators

  • Lumenis Be Ltd.

    lead INDUSTRY

Principal Investigators

  • Daniel Friedmann, MD · Westlake dermatology

  • Jennifer Deaver · The Pearl Dermatology

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-04
Primary Completion
2023-06-23
Completion
2023-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05755139 on ClinicalTrials.gov