Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
NONE
Study Groups
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BabyGentleStick™ ON, then BabyGentleStick™ OFF
Experimental intervention, then Active Comparator.
BabyGentleStick™ ON
experimental intervention
BabyGentleStick™ OFF
active comparator
BabyGentleStick™ OFF, then BabyGentleStick™ ON
Active Comparator, then Experimental intervention.
BabyGentleStick™ ON
experimental intervention
BabyGentleStick™ OFF
active comparator
Interventions
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BabyGentleStick™ ON
experimental intervention
BabyGentleStick™ OFF
active comparator
Eligibility Criteria
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Inclusion Criteria
* Fluent in written and spoken English
* Sex: male or female
Exclusion Criteria
* Cognitive impairment
* Prisoner
* Individuals with known hematologic conditions or bleeding disorders
* Individuals with immune disorders where a finger lance puts them at risk for infection.
18 Years
29 Years
ALL
Yes
Sponsors
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Milton S. Hershey Medical Center
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Actuated Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan Clement, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Actuated Medical, Inc.
Kim K Doheny, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University College of Medicine
Locations
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY00004892
Identifier Type: -
Identifier Source: org_study_id