Quality of Life Clinical Trial
Official title:
A Polychromatic Light Emitting Diode System to Deliver Low Dose Light Directly Into a Peripheral Intravascular Catheter: A Safety and Feasibility Study
Verified date | October 2016 |
Source | UVLrx Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3063 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lozano Medical Clinic | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
UVLrx Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | The improvement in subject quality of life using a five (5)-point GRA | Descriptive scale evaluating subject's perceived quality of life following treatment administration scale | 10 weeks | No |
Secondary | Subject satisfaction based on five (5)-point satisfaction questionnaire | Self-reported overall treatment satisfaction based on perceived response from treatment | 10 weeks | No |
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