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

NCT02785133 | Completed

• 1 other identifier: UVL_0001
• Study Type: interventional
• Target: 3,063
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The improvement in subject quality of life using a five (5)-point GRA

  10 weeks

• Subject satisfaction based on five (5)-point satisfaction questionnaire

  10 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

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.

Device: UVL1000 Treatment Station; Drug: Normal Saline Solution; Device: Peripheral Catheterization

Interventions

UVL1000 Treatment Station 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

Treatment group

Normal Saline Solution DRUG

150 ml of 0.9% Sodium Chloride Solution

Treatment group

Peripheral Catheterization DEVICE

20-gauge 1.0" catheter

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• UVLrx Therapeutics: lead

Study Sites (1)

Lozano Medical Clinic

Dallas, Texas, 75218, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Saline Solution; Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Ryan J Maloney

  Maloney Insights

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: May 27, 2016
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)