An observational study in Catheter Complications, sponsored by Piccolo Medical. Completed at 2 sites in United States. Open to participants aged 22 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-03.
Sponsored by Piccolo Medical · Observational
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.
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.
This is the only study on the registry with Piccolo Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult subjects who have been prescribed a PICC
Exclusion Criteria:
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.
SmartPICC placement efficacy
Technical feasibility will be evaluated as the ability of a 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.
Time frame: Immediately post procedure
SmartPICC safety
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 that no investigational device or investigational procedure related Adverse Events have occurred. A review of subject medical records will also be performed at 7 days post PICC placement to ensure that there was no post procedure phlebitis, thrombosis, or central line-associated bloodstream infection (CLABSI) attributable to the study device.
Time frame: up to 7 days post procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.