N/A
Completed N=20
Feasibility of BabyGentleStick- Adult Pilot Study
Lack of Adverse Events · Reduced Pain Response
Source: ClinicalTrials.gov NCT02947646 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Number of Adverse Events — 0; 1 events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
0; 1 | — |
| SECONDARY Reduced Pain Response |
1.74; 1.80 | — |
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.
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. Informational only — not medical advice.