CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
BabyGentleStick™ ON +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02947646
NCT02947646N/ACompleted
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Feasibility of BabyGentleStick- Adult Pilot Study

Actuated Medical, Inc.·interventional·Posted Oct 28, 2016·Updated Dec 29, 2022

In Brief

A clinical study evaluating BabyGentleStick™ ON and BabyGentleStick™ OFF for Lack of Adverse Events and Reduced Pain Response. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLack of Adverse Events, Reduced Pain Response
CountriesUnited States
CollaboratorsMilton S. Hershey Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 28, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.7 years ago

Interventions

BabyGentleStick™ ONdevice

experimental intervention

BabyGentleStick™ OFFdevice

active comparator