SmartPICC-1 Feasibility Study Technical Feasibility Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Catheter Complications

Intervention / Treatment
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* Device: SmartPICC-1 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided written informed consent, including authorization to release health information Subject between 22-85 years of age at the time of consent Subject is scheduled for PICC placement Subject understands and is able and willing to comply with the study requirements Subject has provided a negative pregnancy test (if subject is a woman of childbearing potential (WOCBP)) Exclusion Criteria: Contraindicated for PICC Subject is enrolled in another clinical study where the safety profile is not yet established or may otherwise confound the SmartPICC-1 Study results Subject is deemed ineligible for the study in the opinion of the investigator, physician, and/or PICC nurse Subject has single ventricle anatomy Subject has a BMI that, in the opinion of the investigator, physician, and/or PICC nurse, would interfere with successful PICC placement Subjects with known stenosis of the upper arm and right-side veins that may prevent successful PICC placement Subject has mechanical circulatory support device (e.g. ECMO, VAD) Subject is pregnant Subject has or is suspected to have COVID-19

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 7 days post procedure |