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OpenTrials
Completed

NCT Number: NCT02947646

Feasibility of BabyGentleStick- Adult Pilot Study

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.

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Key information

Conditions

Lack of Adverse Events Reduced Pain Response

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BabyGentleStick™ ON

Device

experimental intervention

BabyGentleStick™ OFF

Device

active comparator

Primary outcomes

  1. Number 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 outcomes

  1. Reduced Pain Response

    Time frame: 5 minutes

    Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain.

Sponsors and collaborators

Lead sponsor

Actuated Medical, Inc.

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Milton S. Hershey Medical Center

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2016
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.