Lack of Adverse Events, Reduced Pain Response
Conditions
Brief 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.
Interventions
DEVICEBabyGentleStick™ ON
experimental intervention
DEVICEBabyGentleStick™ OFF
active comparator
Sponsors
Milton S. Hershey Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Actuated Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduced Pain Response | 5 minutes | Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BabyGentleStick™ ON, Then BabyGentleStick™ OFF Experimental intervention followed by Active Comparator. | 10 |
| BabyGentleStick™ OFF, Then BabyGentleStick™ ON Active Comparator followed by Experimental intervention. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | BabyGentleStick™ ON, Then BabyGentleStick™ OFF | BabyGentleStick™ OFF, Then BabyGentleStick™ ON | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 1 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Number of Adverse Events
Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events.
Time frame: 24 hours after the intervention is received for each subject
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BabyGentleStick™ ON | Number of Adverse Events | 0 events |
| BabyGentleStick™ OFF | Number of Adverse Events | 1 events |
Secondary
Reduced Pain Response
Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain.
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BabyGentleStick™ ON | Reduced Pain Response | 1.74 score on a Likert scale | Standard Deviation 1.45 |
| BabyGentleStick™ OFF | Reduced Pain Response | 1.80 score on a Likert scale | Standard Deviation 1.24 |