Feasibility of BabyGentleStick- Adult Pilot Study

Not Applicable

Completed

• Conditions: Reduced Pain Response; Lack of Adverse Events
• Interventions: Device: BabyGentleStick™ ON; Device: BabyGentleStick™ OFF

• Registration Number: NCT02947646
• Lead Sponsor: Actuated Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Study Start: 2016-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2022-03-01
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-23
• Results First Posted: 2022-06-16
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BabyGentleStick™ OFF, then BabyGentleStick™ ON	BabyGentleStick™ ON	Active Comparator, then Experimental intervention.
BabyGentleStick™ ON, then BabyGentleStick™ OFF	BabyGentleStick™ ON	Experimental intervention, then Active Comparator.
BabyGentleStick™ OFF, then BabyGentleStick™ ON	BabyGentleStick™ OFF	Active Comparator, then Experimental intervention.
BabyGentleStick™ ON, then BabyGentleStick™ OFF	BabyGentleStick™ OFF	Experimental intervention, then Active Comparator.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	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 Outcome Measures

Name	Time	Method
Reduced Pain Response	5 minutes	Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain.

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States