SmartPICC-1 Feasibility Study Technical Feasibility Study

NCT05548192 | Completed FDA Device

• 1 other identifier: CRD-15-325
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

SmartPICC-1 System DEVICE

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.

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who have been prescribed a PICC

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Piccolo Medical: lead

Study Sites (2)

El Camino Health - Mountain View

San Francisco, California, 94040, United States

Location

CPMC Van Ness

San Francisco, California, 94109, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: April 1, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (2)