Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT03948360
Status:
UNKNOWN
Last Update Posted:
2019-05-13
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
Sponsor:
Rogers Sciences Inc.
Organization:
Study Overview
Official Title:
A First-In-Human Pilot Study of a Novel Wearable Phototherapy System for the Management of Acute Burn Wounds
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: