Clinical Procedures Which Require Vessel Cannulations in Pediatric PatientsNCT04039490
Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
A study testing SCENERGY in people with Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients, run by Clear Guide Medical at 1 site in United States.
Trial summary
Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
- What is being tested?
- SCENERGY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 31 Aug 2025
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- any pediatric patient scheduled for a vessel cannulation at CNMC
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20910
Karun Sharma, MD, 301-565-8447, OPHS@childrensnational.org
About this study
Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.
Read the detailed description
Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.
- Being tested
- SCENERGY
- Keywords
- pediatrics, vessel cannulations, ultrasound-guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCENERGYDevice
Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-only Pediatric Vessel Cannulation | No intervention | The standard of care for vessel cannulation currently employed at CNMC |
| SCENERGY-guided Pediatric Vessel Cannulation | Experimental | The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations. Receives: Device: SCENERGY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful first-attempt vessel cannulation
Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel
Measured: 1 hour
Secondary outcomes (2)
Non-IR Personnel Successfully Cannulate Pediatric Patients
Test if non-specialists can learn to successfully cannulate pediatric patients with only 1 needle puncture.
Measured: 1 hour
Point-of-Care Successful Cannulation
Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start6 Feb 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Procedures Which Require Vessel Cannulations in Pediatric PatientsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Children's National Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039490
- Sponsor's protocol ID
- CNMC Ph II Trial
- Status last verified
- Sep 2024
- First submitted
- 29 Jul 2019
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
- ClinicalTrials.gov ID
- NCT04039490
- Acronym / sponsor ID
- CNMC Ph II Trial
- Keywords
- pediatrics, vessel cannulations, ultrasound-guided
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Children's National Research Institute
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 31 Jul 2019 (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.
Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.
Detailed description
Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-only Pediatric Vessel Cannulation | No intervention | –The standard of care for vessel cannulation currently employed at CNMC |
| SCENERGY-guided Pediatric Vessel Cannulation | Experimental | Device: SCENERGYThe addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- any pediatric patient scheduled for a vessel cannulation at CNMC
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| SCENERGYUse of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations | Device | SCENERGY-guided Pediatric Vessel Cannulation |
Primary outcome
Successful first-attempt vessel cannulation
Time frame: 1 hour
Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel
2 secondary outcomes
Non-IR Personnel Successfully Cannulate Pediatric Patients
Time frame: 1 hour
Point-of-Care Successful Cannulation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCENERGY in people with Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients, run by Clear Guide Medical 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorothee Heisenberg, PhD (4435703835, heisenberg@clearguidemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful first-attempt vessel cannulation (time frame: 1 hour). 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 26 Sep 2024.