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A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

NCT04011306 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-14

No results posted yet for this study

Summary

The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.

Conditions

  • Burn Wound

Interventions

DEVICE

Lumina24 BLU

Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns

Sponsors & Collaborators

  • Rogers Sciences Inc.

    lead INDUSTRY

Principal Investigators

  • David W. Mozingo, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2021-08-31
Completion
2021-08-31
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 NCT04011306 on ClinicalTrials.gov