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Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain

NCT03246282 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-11-14

No results posted yet for this study

Summary

This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.

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 0.9% Infusion Solution Bag

250 ml of 0.9% Sodium Chloride Solution

DEVICE

Peripheral Catheterization

20-gauge 1.0" catheter

Sponsors & Collaborators

  • White Clover Research Foundation

    collaborator OTHER

  • White Clover Wellness and Research Center

    collaborator UNKNOWN

  • John W. Reeves, MD

    lead OTHER

Principal Investigators

  • John W Reeves, MD · White Clover Wellness and Research Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03246282 on ClinicalTrials.gov