SmartPICC-1 Feasibility Study Technical Feasibility Study
Completed
Conditions studied: Catheter Complications
In brief
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.
Key facts
- Study ID
- NCT05548192
- Run by
- Piccolo Medical
- People needed
- 42
- Starts
- 2021-04-01
- Expected to finish
- 2022-08-23
- Last updated by the study team
- 2023-03-03
Who can join
Age: 22 and older, up to 85. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- El Camino Health - Mountain View — San Francisco, California, United States
- CPMC Van Ness — San Francisco, California, United States
Full record on ClinicalTrials.gov
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