Image Guidance for Improved Vessel Cannulation in Pediatric Patients

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04031495

Enrollment

Registered

2019-07-24

Start date

2019-04-22

Completion date

2019-05-10

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Vein Cannulation

Brief 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.

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.

Interventions

DEVICECentral Vein Cannulation

Central Vein Cannulation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Inclusion criteria

* pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Successful Central Vein Cannulation	1 day	device enabled successful cannulation on the first pass showing feasibility to aid in cvcs

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKarun Sharma, MD

Children's National Research Institute

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	9 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Age, Continuous	11.4 years STANDARD_DEVIATION 3.5
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	7 Participants
Region of Enrollment United States	9 Participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	4 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 9
other Total, other adverse events	0 / 9
serious Total, serious adverse events	0 / 9

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026