Pain From Heel SticksNCT03066895
BGS Neonatal Pilot Study
A study testing BabyGentleStick and Standard Lancing Device in people with Pain From Heel Sticks, 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 35 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain From Heel Sticks
- What is being tested?
- BabyGentleStick and Standard Lancing Device
- 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
- 6 Nov 2017to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically stable late preterm/term neonates with a gestational age at birth of > 35 weeks gestation at birth
- Sex: male or female
Who cannot join
- Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
- Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
- Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
- Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
- Critical illness in the mother preventing the ability to obtain informed consent from parents
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
Official title: Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot 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
- Pain From Heel Sticks
- Being tested
- BabyGentleStick, Standard Lancing Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyGentleStickDevice
Experimental device.
Standard Lancing DeviceDevice
HMC standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | BabyGentleStick Receives: Device: BabyGentleStick |
| Standard of Care | Active comparator | HMC Standard Lancing Device Receives: Device: Standard Lancing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
No device-attributable adverse events.
Measured: Up to 8 days
Secondary outcomes (1)
Pain Response
Pain level at specified study intervals measured on Neonatal Facial Coding System (NFCS) scale
Measured: 2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start6 Nov 2017
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain From Heel SticksStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- 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), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ryan Clement, Ph.D., Principal investigator, Actuated Medical, Inc.Kim Doheny, Ph.D., Principal investigator, The Pennsylvania State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066895
- Sponsor's protocol ID
- STUDY00006878
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2017
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of BabyGentleStick™ Vibrated Needle System for Heel Lance- Neonatal Pilot Study
- ClinicalTrials.gov ID
- NCT03066895
- Acronym / sponsor ID
- STUDY00006878
- Conditions
- Pain From Heel Sticks
- 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), National Institutes of Health (NIH)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: BabyGentleStickBabyGentleStick |
| Standard of Care | Active comparator | Device: Standard Lancing DeviceHMC Standard Lancing Device |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Medically stable late preterm/term neonates with a gestational age at birth of > 35 weeks gestation at birth
- Sex: male or female
Key exclusion criteria (5 listed)
- Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements
- Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)
- Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)
- Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)
- Critical illness in the mother preventing the ability to obtain informed consent from parents
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 |
|---|---|---|
| BabyGentleStickExperimental device. | Device | Experimental |
| Standard Lancing DeviceHMC standard of care. | Device | Standard of Care |
Primary outcome
Adverse events
Time frame: Up to 8 days
No device-attributable adverse events.
1 secondary outcome
Pain Response
Time frame: 2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- 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 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 and Standard Lancing Device in people with Pain From Heel Sticks, 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 2 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 14 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events (time frame: Up to 8 days). 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 14 Sep 2020.