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Clinical Trials/NCT02947646
NCT02947646
Completed
Not Applicable

Feasibility of BabyGentleStick- Adult Pilot Study

Actuated Medical, Inc.1 site in 1 country20 target enrollmentNovember 2016
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ConditionsLack of Adverse EventsReduced Pain Response

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lack of Adverse Events
Sponsor
Actuated Medical, Inc.
Enrollment
20
Locations
1
Primary Endpoint
Number of Adverse Events
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
December 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Actuated Medical, Inc.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy adult volunteers 18-29 years of age.
  • •Fluent in written and spoken English
  • •Sex: male or female

Exclusion Criteria

  • •Pregnant women
  • •Cognitive impairment
  • •Individuals with known hematologic conditions or bleeding disorders
  • •Individuals with immune disorders where a finger lance puts them at risk for infection.

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: 24 hours after the intervention is received for each subject

Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events.

Secondary Outcomes

  • Reduced Pain Response(5 minutes)

Study Sites (1)

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