Central Vein CannulationNCT04031495
Image Guidance for Improved Vessel Cannulation in Pediatric Patients
A study testing Central Vein Cannulation in people with Central Vein Cannulation, run by Clear Guide Medical at 1 site in United States.
Trial summary
Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Central Vein Cannulation
- What is being tested?
- Central Vein Cannulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 10 May 2019
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20910
About this study
Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.
Read the detailed description
Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.
- Conditions
- Central Vein Cannulation
- Being tested
- Central Vein Cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Vein CannulationDevice
Central Vein Cannulation
| Study group | Role | What they receive |
|---|---|---|
| Central Vein Cannulation using Clear Guide SCENERGY system | Experimental | The Clear Guide navigation system will be used for central venous catheter (CVC) placement in pediatric patients. This is a single site pilot/feasibility study. We will test the feasibility of using this system in pediatric patients who are undergoing CVC placement by the Interventional Radiology team in the operating room as part of their routine clinical care. Receives: Device: Central Vein Cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Central Vein Cannulation
device enabled successful cannulation on the first pass showing feasibility to aid in cvcs
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start22 Apr 2019
- Primary completion10 May 2019
- Study completion10 May 2019
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 Central Vein CannulationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Karun Sharma, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031495
- Sponsor's protocol ID
- 1R44HD096974-01
- Status last verified
- Jul 2019
- First submitted
- 17 Apr 2019
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guidance for Improved Vessel Cannulation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04031495
- Acronym / sponsor ID
- 1R44HD096974-01
- Conditions
- Central Vein Cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.
Detailed description
Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central Vein Cannulation using Clear Guide SCENERGY system | Experimental | Device: Central Vein CannulationThe Clear Guide navigation system will be used for central venous catheter (CVC) placement in pediatric patients. This is a single site pilot/feasibility study. We will test the feasibility of using this system in pediatric patients who are undergoing CVC placement by the Interventional Radiology team in the operating room as part of their routine clinical care. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation
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 |
|---|---|---|
| Central Vein CannulationCentral Vein Cannulation | Device | Central Vein Cannulation using Clear Guide SCENERGY system |
Primary outcome
Successful Central Vein Cannulation
Time frame: 1 day
device enabled successful cannulation on the first pass showing feasibility to aid in cvcs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Central Vein Cannulation
Not yet recruiting
Venipuncture Via Nurse-AI Collaboration
Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination, Peripheral Venous Access Establishment
Not yet recruitingObservational study
Ultrasound Assessment of Internal Jugular Vein for Cannulation and Venous Pressure Prediction
Vascular Access, Elevated Jugular Venous Pressure
Not yet recruiting
Comparison of Short-Axis and Long-Axis Internal Jugular Vein Cannulation for First-Pass Success
Cannulation of Internal Jugular Vein
Recruiting
The INVADE Study: INnominate Vein Approach for Central Catheterization in Difficult to cannulatE Patients
Critical Illness
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.
Karun Sharma, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central Vein Cannulation in people with Central Vein Cannulation, 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: finished, as of the sponsor's last update on 30 Jul 2026. 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 30 Jul 2026). 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?
Successful Central Vein Cannulation (time frame: 1 day). 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 30 Jul 2026.