NCT04039490

Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Clear Guide Medical · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.

Detailed description

Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.

Conditions

• Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Interventions

Type	Name	Description
DEVICE	SCENERGY	Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2019-07-31
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study