Image Guidance for Improved Vessel Cannulation in Pediatric Patients

Clear Guide Medical

Status: Completed

Conditions: Central Vein Cannulation

Treatments: Device: central vein cannulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04031495

1R44HD096974-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)