Feasibility of BabyGentleStick- Adult Pilot Study

Actuated Medical

Status: Completed

Conditions: Reduced Pain Response; Lack of Adverse Events

Treatments: Device: BabyGentleStick™ ON; Device: BabyGentleStick™ OFF

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02947646

R41HD088139 (U.S. NIH Grant/Contract)

STUDY00004892

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

BabyGentleStick™ ON, then BabyGentleStick™ OFF

Experimental group

Description:

Experimental intervention, then Active Comparator.

Treatment:

Device: BabyGentleStick™ OFF

Device: BabyGentleStick™ ON

BabyGentleStick™ OFF, then BabyGentleStick™ ON

Experimental group

Description:

Active Comparator, then Experimental intervention.

Treatment:

Device: BabyGentleStick™ OFF

Device: BabyGentleStick™ ON