NCT03066895

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 17, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

February 17, 2017

Last Update Submit

September 10, 2020

Conditions

Pain From Heel Sticks

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    No device-attributable adverse events.

    Up to 8 days

Secondary Outcomes (1)

  • Pain Response

    2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure

Study Arms (2)

Experimental

EXPERIMENTAL

BabyGentleStick

Device: BabyGentleStick

Standard of Care

ACTIVE COMPARATOR

HMC Standard Lancing Device

Device: Standard Lancing Device

Interventions

BabyGentleStickDEVICE

Experimental device.

Experimental
Standard Lancing DeviceDEVICE

HMC standard of care.

Standard of Care

Eligibility Criteria

Age35 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Medically stable late preterm/term neonates with a gestational age at birth of \> 35 weeks gestation at birth
  • Sex: male or female

You may not qualify if:

  • Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
  • Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
  • Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
  • Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
  • Critical illness in the mother preventing the ability to obtain informed consent from parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Ryan Clement, Ph.D.

    Actuated Medical, Inc.

    PRINCIPAL INVESTIGATOR

  • Kim Doheny, Ph.D.

    The Pennsylvania State University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 1, 2017

Study Start

November 6, 2017

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)