A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
NCT01786408 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2014-11-25
Summary
This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.
Conditions
Interventions
- DEVICE
-
TAP20-C
- DEVICE
-
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
Sponsors & Collaborators
-
Seventh Sense Biosystems
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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