NCT05548192

SmartPICC-1 Feasibility Study Technical Feasibility Study

Evaluation of the SmartPICC System for PICC Placement in Adults: A Safety and Technical Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Piccolo Medical · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the safety and technical feasibility of the Piccolo Medical SmartPICC System, indicated for guidance and positioning of commercially available central venous catheters, for PICC placement in adults.

Detailed description

The primary objective of this study is to evaluate the safety and technical feasibility of the Piccolo Medical SmartPICC System for PICC placement in adults. The SmartPICC system is indicated for guidance and positioning of commercially available central venous catheters. In this prospective, single arm (non-randomized), safety and technical feasibility study, adult volunteers who meet the protocol entry criteria and are scheduled to undergo PICC placement will be recruited. Immediately following placement with use of the SmartPICC System, subjects will undergo an assessment of the PICC placement site, as technical feasibility will be evaluated as the ability of the SmartPICC System to provide venous navigation for PICC placement in the lower superior vena cava (L-SVC), cavoatrial junction (CAJ), or proximal right atrium (RA) as confirmed by radiologic review. Safety will be evaluated as freedom from serious adverse events (SAEs) directly attributable to the SmartPICC system. Subjects will be evaluated at 12-24 hours post-placement to ensure safety, in addition to a review of subject medical records 7 days post PICC placement.

Conditions

• Catheter Complications

Interventions

Type	Name	Description
DEVICE	SmartPICC-1 System	The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system provides a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation during PICC placement.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-08-23
• Completion: 2022-08-23
• First posted: 2022-09-21
• Last updated: 2023-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study