N/A N=20 Randomized Device Feasibility

Feasibility of BabyGentleStick- Adult Pilot Study

Lack of Adverse Events · Reduced Pain Response

Bottom Line

View on ClinicalTrials.gov: NCT02947646 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Number of Adverse Events — 0; 1 events

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BabyGentleStick™ ON (Device); BabyGentleStick™ OFF (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Actuated Medical, Inc.
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events	0; 1	—
SECONDARY Reduced Pain Response	1.74; 1.80	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02947646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.