SmartPICC-1 Feasibility Study Technical Feasibility Study (NCT05548192) | Clinical Trial Compass
CompletedNot Applicable
SmartPICC-1 Feasibility Study Technical Feasibility Study
United States42 participantsStarted 2021-04-01
Plain-language 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.
Who can participate
Age range
22 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.