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BGS Neonatal Pilot Study

NCT03066895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-14

No results posted yet for this study

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

  • Pain From Heel Sticks

Interventions

DEVICE

BabyGentleStick

Experimental device.

DEVICE

Standard Lancing Device

HMC standard of care.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER

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

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Actuated Medical, Inc.

    lead INDUSTRY

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
35 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Device
Yes

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 NCT03066895 on ClinicalTrials.gov