Catheter ComplicationsNCT05548192
SmartPICC-1 Feasibility Study Technical Feasibility Study
An observational study of Catheter Complications, run by Piccolo Medical at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheter Complications
- What is being tested?
- SmartPICC-1 System
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 23 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects who have been prescribed a PICC
Who may be able to join
- 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))
Who cannot join
- 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
Show all 9Show fewer
- Subject has mechanical circulatory support device (e.g. ECMO, VAD)
- Subject is pregnant
- Subject has or is suspected to have COVID-19
Trial locations and contacts
2 sites in 1 country.
United States2 sites
El Camino Health - Mountain View
San Francisco, California, 94040
CPMC Van Ness
San Francisco, California, 94109
About this study
Official title: Evaluation of the SmartPICC System for PICC Placement in Adults: A Safety and Technical Feasibility Study
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.
Read the 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
- Being tested
- SmartPICC-1 System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartPICC-1 SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 7 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Apr 2021
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piccolo Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548192
- Sponsor's protocol ID
- CRD-15-325
- Status last verified
- Mar 2023
- First submitted
- 16 Sep 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SmartPICC System for PICC Placement in Adults: A Safety and Technical Feasibility Study
- ClinicalTrials.gov ID
- NCT05548192
- Acronym / sponsor ID
- CRD-15-325
- Conditions
- Catheter Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Piccolo MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who have been prescribed a PICC
Key inclusion criteria (5 listed)
- 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))
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartPICC-1 SystemThe 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. | Device | – |
Primary outcome
SmartPICC placement efficacy
Time frame: Immediately post procedure
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.
SmartPICC safety
Time frame: up to 7 days post procedure
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Complications, run by Piccolo Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SmartPICC placement efficacy (time frame: Immediately post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.