Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of BabyGentleStick- Adult Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02947646
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Actuated Medical, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Lack of Adverse Events Reduced Pain Response Device: BabyGentleStick™ ON Device: BabyGentleStick™ OFF Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: BabyGentleStick™ ON
Experimental intervention to be compared to the Active Comparator.
 Device: BabyGentleStick™ ON
Active Comparator: BabyGentleStick™ OFF
Active Comparator intervention to be compared to the Experimental Treatment.
 Device: BabyGentleStick™ OFF


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Absence 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.


Secondary Outcome Measures :
  1. Reduced Pain Response [ Time Frame: Up to 8 weeks ]
    Relative pain scale from 1 to 10


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947646


Locations
Layout table for location information
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Actuated Medical, Inc.
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Ryan Clement, Ph.D. Actuated Medical, Inc.
Principal Investigator: Kim K Doheny, Ph.D. The Pennsylvania State University College of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Actuated Medical, Inc.
ClinicalTrials.gov Identifier: NCT02947646    
Other Study ID Numbers: STUDY00004892
R41HD088139 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No