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| ID | Type | Description | Link |
|---|---|---|---|
| R41HD088139 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BabyGentleStick™ ON, then BabyGentleStick™ OFF | Experimental | Experimental intervention, then Active Comparator. |
|
| BabyGentleStick™ OFF, then BabyGentleStick™ ON | Experimental | Active Comparator, then Experimental intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BabyGentleStick™ ON | Device | experimental intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events. | 24 hours after the intervention is received for each subject |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced Pain Response | Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain. | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Clement, Ph.D. | Actuated Medical, Inc. | Principal Investigator |
| Kim K Doheny, Ph.D. | The Pennsylvania State University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BabyGentleStick™ ON, Then BabyGentleStick™ OFF | Experimental intervention first (5 minutes), followed by Active Comparator (5 minutes). |
| FG001 | BabyGentleStick™ OFF, Then BabyGentleStick™ ON | Active Comparator first (5 minutes), then Experimental intervention (5 minutes). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BabyGentleStick™ ON, Then BabyGentleStick™ OFF | Experimental intervention followed by Active Comparator. |
| BG001 | BabyGentleStick™ OFF, Then BabyGentleStick™ ON | Active Comparator followed by Experimental intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events. | Posted | Number | events | 24 hours after the intervention is received for each subject |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BabyGentleStick™ ON | Experimental intervention to be compared to the Active Comparator. BabyGentleStick™ ON |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexpected bleeding | Blood and lymphatic system disorders | Systematic Assessment | Unexpected bleeding with first lancet puncture (vibration off). Required pressure to site for >12 min to stop bleeding. PI elected to stop study for this enrollee and not perform procedure with vibration on. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Quality Assurance & Regulatory Affairs | Actuated Medical | 814-355-0003 | medical.affairs@actuatedmedical.com |
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| BabyGentleStick™ OFF | Device | active comparator |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Reduced Pain Response | Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain. | Posted | Mean | Standard Deviation | score on a Likert scale | 5 minutes |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | BabyGentleStick™ OFF | Active Comparator intervention to be compared to the Experimental interventional. BabyGentleStick™ OFF | 0 | 20 | 0 | 20 | 1 | 20 |
|
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