Safety and Feasibility of Polychromatic Light Emitting Diode for Peripheral Catheter Illumination During Peripheral Intravenous Delivery of Normal Saline
Condition: Quality of Life; Fatigue
Study type: Interventional

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.
    

Intervention name(s): UVL1000 Treatment Station; Normal Saline Solution; Peripheral Catheterization
Intervention type(s): Device; Drug; Device
Intervention description(s): 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; 150 ml of 0.9% Sodium Chloride Solution; 20-gauge 1.0" catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment