Image Guidance for Improved Vessel Cannulation in Pediatric Patients

Not Applicable

Completed

• Conditions: Central Vein Cannulation

• Registration Number: NCT04031495
• Lead Sponsor: Clear Guide Medical

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.

Study Timeline

• Study First Submitted: 2019-04-17
• Study Start: 2019-04-22
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-10
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-22
• Last Update Submitted: 2019-07-22
• Study First Posted: 2019-07-24
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States