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Feasibility of BabyGentleStick- Adult Pilot Study

NCT02947646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-29

Study results available
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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.

Conditions

  • Lack of Adverse Events
  • Reduced Pain Response

Interventions

DEVICE

BabyGentleStick™ ON

experimental intervention

DEVICE

BabyGentleStick™ OFF

active comparator

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Actuated Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ryan Clement, Ph.D. · Actuated Medical, Inc.

  • Kim K Doheny, Ph.D. · The Pennsylvania State University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947646 on ClinicalTrials.gov