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BD MiniDraw™ Capillary System Clinical Equivalence Study

NCT05186311 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2023-11-03

Study results available
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Summary

This study designed to evaluate the safety and effectiveness of a newly developed sample collection device. Participants will be enrolled and samples will be collected by representative future users of the device. Comparator venous and conventional capillary tubes will be collected by skilled healthcare professionals with phlebotomy experience. Samples will be tested and average differences between the investigational device compared to a marketed comparator will be evaluated. Visual observations will be captured and device safety will be assessed.

Conditions

  • Healthy
  • Disease, Chronic
  • Acute Disease
  • Sample Collection

Interventions

DEVICE

Capillary Blood Collection System

Test Blood Sample Collection

Sponsors & Collaborators

  • Babson Diagnostics

    collaborator INDUSTRY

  • Becton, Dickinson and Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2022-10-24
Completion
2022-10-24

Countries

  • United States

Study Locations

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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 NCT05186311 on ClinicalTrials.gov