Image Guidance for Improved Vessel Cannulation in Pediatric Patients

Clear Guide Medical4 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Central Vein Cannulation

Interventions

central vein cannulationDEVICE

central vein cannulation

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation Exclusion Criteria: * none

Locations (1)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Successful Central Vein Cannulation

device enabled successful cannulation on the first pass showing feasibility to aid in cvcs

Time frame: 1 day

Data from ClinicalTrials.gov

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