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Lancet Blood Volume Comparison Study

NCT01916096 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2013-08-05

No results posted yet for this study

Summary

The primary objective of the study examines the success rate of various OneTouch Delica lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4 times with two lancet sizes at a single depth setting. There will be 120 paired lancing events for each lancet size within the group.

Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings.

Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings is less than 90%.

Conditions

Interventions

DEVICE

Delica Device

Sponsors & Collaborators

  • Facet Technologies

    lead OTHER

Principal Investigators

  • Barry Ginsberg, MD · Facet Technologies

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01916096 on ClinicalTrials.gov