SmartPICC-1 Feasibility Study Technical Feasibility Study
NCT05548192 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42
Last updated 2023-03-03
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.
Conditions
- Catheter Complications
Interventions
- 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.
Sponsors & Collaborators
-
Piccolo Medical
lead INDUSTRY
Eligibility
- Min Age
- 22 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2022-08-23
- Completion
- 2022-08-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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