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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UVLrx Therapeutics

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