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

NCT ID: NCT02785133

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3063 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-10-31

Brief 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.

Detailed 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.

Conditions

Quality of Life; Fatigue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Polychromatic light emitting diode system is a non-significant risk device that administers low-dose light generated by a light emitting diode. Small adapter attaches directly to a standard 20-gauge catheter that threads a small fiber optic through the distal end of the catheter. The optic terminates at the distal end of the catheter. Polychromatic light is emitted to illuminate the catheter and site of catheter entrance. Concurrently, normal saline flows through the optic adapter and through into the 20-gauge catheter.

Group Type: EXPERIMENTAL

UVL1000 Treatment Station

Intervention Type: DEVICE

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

Normal Saline Solution

Intervention Type: DRUG

150 ml of 0.9% Sodium Chloride Solution

Peripheral Catheterization

Intervention Type: DEVICE

20-gauge 1.0" catheter

Interventions

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

Intervention Type: DEVICE

Normal Saline Solution

150 ml of 0.9% Sodium Chloride Solution

Intervention Type: DRUG

Peripheral Catheterization

20-gauge 1.0" catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UVLrx Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan J Maloney

Role: STUDY_DIRECTOR

Maloney Insights

Locations

Lozano Medical Clinic

Dallas, Texas, United States

Countries

United States

Other Identifiers

UVL_0001

Identifier Type: -

Identifier Source: org_study_id