Feasibility of BabyGentleStick- Adult Pilot Study
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
June 16, 2022
CompletedDecember 29, 2022
May 1, 2022
1 month
October 25, 2016
March 1, 2022
December 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Reduced Pain Response
5 minutes
Study Arms (2)
BabyGentleStick™ ON, then BabyGentleStick™ OFF
EXPERIMENTALExperimental intervention, then Active Comparator.
BabyGentleStick™ OFF, then BabyGentleStick™ ON
EXPERIMENTALActive Comparator, then Experimental intervention.
Interventions
experimental intervention
active comparator
Eligibility Criteria
You may qualify if:
- Healthy adult volunteers 18-29 years of age.
- Fluent in written and spoken English
- Sex: male or female
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Results Point of Contact
- Title
- Director Quality Assurance & Regulatory Affairs
- Organization
- Actuated Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Clement, Ph.D.
Actuated Medical, Inc.
- PRINCIPAL INVESTIGATOR
Kim K Doheny, Ph.D.
The Pennsylvania State University College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 28, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 29, 2022
Results First Posted
June 16, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share