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NCT01786408 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01786408 on ClinicalTrials.gov