Lack of Adverse Events Clinical Trial
| Verified date | May 2022 |
| Source | Actuated Medical, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStickâ˘; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 29 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Actuated Medical, Inc. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Milton S. Hershey Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Reduced Pain Response | Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain. | 5 minutes |