Lack of Adverse EventsNCT02947646
Feasibility of BabyGentleStick- Adult Pilot Study
A study testing BabyGentleStick™ ON and BabyGentleStick™ OFF in people with Lack of Adverse Events and Reduced Pain Response, run by Actuated Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Lack of Adverse Events, Reduced Pain Response
- What is being tested?
- BabyGentleStick™ ON and BabyGentleStick™ OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers 18-29 years of age.
- Fluent in written and spoken English
- Sex: male or female
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Lack of Adverse Events, Reduced Pain Response
- Being tested
- BabyGentleStick™ ON, BabyGentleStick™ OFF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyGentleStick™ ONDevice
experimental intervention
BabyGentleStick™ OFFDevice
active comparator
| Study group | Role | What they receive |
|---|---|---|
| BabyGentleStick™ ON, then BabyGentleStick™ OFF | Experimental | Experimental intervention, then Active Comparator. Receives: Device: BabyGentleStick™ ON; Device: BabyGentleStick™ OFF |
| BabyGentleStick™ OFF, then BabyGentleStick™ ON | Experimental | Active Comparator, then Experimental intervention. Receives: Device: BabyGentleStick™ ON; Device: BabyGentleStick™ OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Subjects will receive a follow-up phone call 24 hours post-intervention to monitor adverse events.
Measured: 24 hours after the intervention is received for each subject
Secondary outcomes (1)
Reduced Pain Response
Relative Likert pain scale from 1 to 10, with 0 being no pain and 10 being extreme pain.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lack of Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actuated Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ryan Clement, Ph.D., Principal investigator, Actuated Medical, Inc.Kim K Doheny, Ph.D., Principal investigator, The Pennsylvania State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947646
- Sponsor's protocol ID
- STUDY00004892
- Other IDs
- R41HD088139
- Status last verified
- May 2022
- First submitted
- 25 Oct 2016
- Last updated
- 29 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of BabyGentleStick- Adult Pilot Study
- ClinicalTrials.gov ID
- NCT02947646
- Acronym / sponsor ID
- STUDY00004892
- Conditions
- Lack of Adverse Events, Reduced Pain Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Actuated Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 16 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BabyGentleStick™ ON, then BabyGentleStick™ OFF | Experimental | Device: BabyGentleStick™ ON, Device: BabyGentleStick™ OFFExperimental intervention, then Active Comparator. |
| BabyGentleStick™ OFF, then BabyGentleStick™ ON | Experimental | Device: BabyGentleStick™ ON, Device: BabyGentleStick™ OFFActive Comparator, then Experimental intervention. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers 18-29 years of age.
- Fluent in written and spoken English
- Sex: male or female
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BabyGentleStick™ ONexperimental intervention | Device | BabyGentleStick™ OFF, then BabyGentleStick™ ON, BabyGentleStick™ ON, then BabyGentleStick™ OFF |
| BabyGentleStick™ OFFactive comparator | Device | BabyGentleStick™ OFF, then BabyGentleStick™ ON, BabyGentleStick™ ON, then BabyGentleStick™ OFF |
Primary outcome
Number of Adverse Events
Time frame: 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.
1 secondary outcome
Reduced Pain Response
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Clement, Ph.D. principal investigator
Actuated Medical, Inc.
Kim K Doheny, Ph.D. principal investigator
The Pennsylvania State University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BabyGentleStick™ ON and BabyGentleStick™ OFF in people with Lack of Adverse Events and Reduced Pain Response, run by Actuated Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 24 hours after the intervention is received for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.