Clinical trial NCT05548192: SmartPICC-1 Feasibility Study Technical Feasibility Study
Official title: Evaluation of the SmartPICC System for PICC Placement in Adults: A Safety and Technical Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Complications
Lead sponsor: Piccolo Medical
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 42
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects who have been prescribed a PICC

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.

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

Primary outcomes:
measure: SmartPICC placement efficacy
timeFrame: Immediately post procedure
measure: SmartPICC safety
timeFrame: up to 7 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: El Camino Health - Mountain View
state: California
city: San Francisco
country: United States
facility: CPMC Van Ness
state: California
Study officials:
References: