Safety and Feasibility of Polychromatic Light Emitting Diode for Peripheral Catheter Illumination During Peripheral Intravenous Delivery of Normal Saline
Completed · Not applicable
Conditions studied: Quality of Life, Fatigue
In brief
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.
Key facts
- Study ID
- NCT02785133
- Run by
- UVLrx Therapeutics
- People needed
- 3063
- Starts
- 2014-12-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-10-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lozano Medical Clinic — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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