SmartPICC-1 Feasibility Study Technical Feasibility Study

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

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.

Study Overview

• Status: Completed
• Conditions: Catheter Complications
• Intervention / Treatment: Device: SmartPICC-1 System

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

• Study Contact: Name: John McKenzie; Phone Number: 650-208-5355; Email: jmckenzie@piccolomedical.com
• Study Contact Backup: Name: Anjali Gehani, MS; Phone Number: 646-257-0706; Email: agehani@theranova.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94040
      • El Camino Health - Mountain View
    • San Francisco, California, United States, 94109
      • CPMC Van Ness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who have been prescribed a PICC

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Piccolo Medical

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CRD-15-325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No