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

Quality of Life Clinical Trial

Official title:

A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Safety and Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785133
• Other study ID #: UVL_0001
• Status: Completed
• Phase: N/A
• First received: January 8, 2016
• Last updated: October 25, 2016
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: UVLrx Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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 cursory utility of a low-light source integrated into an existing peripheral intravenous 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 peripheral intravascular catheter to improve self-reported overall subject energy levels based on the change in Epworth Sleepiness scores.

Peripheral intravascular therapy has been used for decades as an effective therapy to maintain proper hydration and electrolyte levels, and has been deemed a non-significant medical procedure. Peripheral intravascular therapy can be infused with various molecular agents such as supplements (Vitamin B12) for the purpose of improving energy levels and overall quality of life. However, the use of normal saline as a standard alone helps improve hydration and cell function. Low-energy light therapy has been established as an alternative treatment for a myriad of medical conditions. Light-based therapy stimulates photoreceptors found within cells and can improve overall cellular bioenergetics. The concurrent administration of low-light therapy and peripheral intravascular normal saline therapy may serve as a viable therapy for the treatment for improvement in subject quality of life and energy levels Accordingly, this study is designed to assess the safety, feasibility, and cursory improvement in self-reported energy levels following intervention of low-light therapy integrated into a standard peripheral intravascular catheter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3063
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Voluntarily signed informed consent form

• Ages 18-70

• Completed urine pregnancy examination with negative result

• Self-reported energy level of >4 on the Epworth sleepiness test

• No breastfeeding for 3 months prior to enrollment

Exclusion Criteria:

• Active infection along potential intravenous catheter sites

• Pacemaker

• Currently taking prescription blood thinning medications (i.e. Warfarin)

• Suffering from a chronic, progressive blood disorder, such as blood cancer (Thalassemia, Lymphoma, Myeloma, etc.)

• Use of anti-inflammatory medications on a chronic basis (i.e. ibuprofen, aspirin, and steroids)

• Suffering from blood clotting disorders (hypercoagulable condition, thrombocytosis, etc.)

• Clinically significant anxiety and/or depression

• Participated in a clinical study in the last 30 days

• Clinical Cardiac Disease

• Active Infection

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
United States	Lozano Medical Clinic	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
UVLrx Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The use of polychromatic light therapy delivered through an intravascular catheter for the improvement in self-reported subject energy levels	The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. It has become the world standard method for making this assessment.; The Epworth Sleepiness Scale will be used to evaluate subject energy levels at both baseline and post-procedure administration phase. Subjects will rate, on a 4-point scale (0 - 3), their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives, although not necessarily every day. It evaluates what the chances are that they would doze off whenever they were in each situation.	Baseline and 10 weeks	No
Secondary	The improvement in subject quality of life using a five (5)-point GRA	Descriptive scale evaluating subject's perceived quality of life following treatment administration scale	10 weeks	No
Secondary	Subject satisfaction based on five (5)-point satisfaction questionnaire	Self-reported overall treatment satisfaction based on perceived response from treatment	10 weeks	No