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Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

Burn Wound Clinical Trial

Official title:
A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds

Clinical Trial Summary

The primary purpose of this first-in-human, early feasibility study is to assess safety and feasibility of the Low-Irradiance Monochromatic Biostimulation (LIMB) System as a phototherapeutic intervention for the management of acute burn wounds. The prototype LIMB device will be evaluated for the occurrence of adverse events (treatment-related or otherwise) of the LIMB System, a portable, wearable, light-emitting system developed by Rogers Sciences, Inc. (RSI). The device will be administered in the small feasibility pilot to confirm design, usability and operating specifications that will inform procedures and endpoints of a subsequent large, multicenter clinical trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03948360
Study type Interventional
Source Rogers Sciences Inc.
Contact
Status Recruiting
Phase N/A
Start date September 7, 2017
Completion date December 31, 2019
View Details
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