Feasibility of BabyGentleStick- Adult Pilot Study

December 28, 2022 updated by: Actuated Medical, Inc.
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
24 hours after the intervention is received for each subject

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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