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Safety and Feasibility of Polychromatic Light Emitting Diode for Peripheral Catheter Illumination During Peripheral Intravenous Delivery of Normal Saline

NCT02785133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3063

Last updated 2016-10-26

No results posted yet for this study

Summary

This study uses a prospective non-randomized, non-controlled design. Five-hundred (500) subjects having previously received a peripheral intravenous therapy will be enrolled into a single treatment group. The purpose of the study is to evaluate the safety, feasibility, and improved energy levels following treatment with a low-light source integrated into an existing peripheral intravascular catheter. The absence of a control group is based on the following reason:This is a pilot investigation to establish a baseline understanding of the safety, feasibility, and cursory utility of polychromatic light emitting diodes integrated into an existing 20-gauge 1.0 inch intravenous catheter to improve self-reported overall subject energy levels.

Conditions

Interventions

DEVICE

UVL1000 Treatment Station

Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0" catheter

DRUG

Normal Saline Solution

150 ml of 0.9% Sodium Chloride Solution

DEVICE

Peripheral Catheterization

20-gauge 1.0" catheter

Sponsors & Collaborators

  • UVLrx Therapeutics

    lead INDUSTRY

Principal Investigators

  • Ryan J Maloney · Maloney Insights

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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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 NCT02785133 on ClinicalTrials.gov