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

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ClinicalTrials.gov Identifier: NCT02785133
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
UVLrx Therapeutics

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE May 27, 2016
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
The use of polychromatic light therapy delivered through an intravascular catheter for the improvement in self-reported subject energy levels [ Time Frame: Baseline and 10 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • The improvement in subject quality of life using a five (5)-point GRA [ Time Frame: 10 weeks ]
    Descriptive scale evaluating subject's perceived quality of life following treatment administration scale
  • Subject satisfaction based on five (5)-point satisfaction questionnaire [ Time Frame: 10 weeks ]
    Self-reported overall treatment satisfaction based on perceived response from treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of Polychromatic Light Emitting Diode for Peripheral Catheter Illumination During Peripheral Intravenous Delivery of Normal Saline
Official Title  ICMJE A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Safety and Feasibility Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Quality of Life
  • Fatigue
Intervention  ICMJE
  • Device: 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
  • Drug: Normal Saline Solution
    150 ml of 0.9% Sodium Chloride Solution
  • Device: Peripheral Catheterization
    20-gauge 1.0" catheter
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Device: UVL1000 Treatment Station
  • Drug: Normal Saline Solution
  • Device: Peripheral Catheterization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
3063
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
500
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02785133
Other Study ID Numbers  ICMJE UVL_0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: At this juncture, there is no specific plan to share data with any regulatory agency for the purposes of 510k market clearance or there is no determination at this juncture to present data to the medical community (i.e. peer-reviewed publication of medical conference)
Responsible Party UVLrx Therapeutics
Study Sponsor  ICMJE UVLrx Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ryan J Maloney Maloney Insights
PRS Account UVLrx Therapeutics
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP