Feasibility of BabyGentleStick- Adult Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Lack of Adverse Events; Reduced Pain Response
• Intervention / Treatment: Device: BabyGentleStick™ ON; Device: BabyGentleStick™ OFF

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BabyGentleStick™ ON, then BabyGentleStick™ OFF; Experimental intervention, then Active Comparator.	Device: BabyGentleStick™ ON; experimental intervention; Device: BabyGentleStick™ OFF; active comparator
Experimental: BabyGentleStick™ OFF, then BabyGentleStick™ ON; Active Comparator, then Experimental intervention.	Device: BabyGentleStick™ ON; experimental intervention; Device: BabyGentleStick™ OFF; active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events.	24 hours after the intervention is received for each subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced Pain Response	Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain.	5 minutes

Collaborators and Investigators

• Sponsor: Actuated Medical, Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Kim K Doheny, Ph.D., The Pennsylvania State University College of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004892; R41HD088139 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No