SmartPICC-1 Feasibility Study Technical Feasibility Study

NCT ID: NCT05548192

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-08-23

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.

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.

Conditions

Catheter Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Piccolo Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

El Camino Health - Mountain View

San Francisco, California, United States

CPMC Van Ness

San Francisco, California, United States

Countries

United States

Other Identifiers

CRD-15-325

Identifier Type: -

Identifier Source: org_study_id