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SmartPICC-1 Feasibility Study Technical Feasibility Study

Sponsor
Piccolo Medical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05548192
Collaborator
(none)
70
Enrollment
2
Locations
19
Anticipated Duration (Months)
35
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SmartPICC-1 System

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

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the SmartPICC System for PICC Placement in Adults: A Safety and Technical Feasibility Study
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

  1. SmartPICC placement efficacy [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.

  2. SmartPICC safety [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 El Camino Health - Mountain View San Francisco California United States 94040
2 CPMC Van Ness San Francisco California United States 94109

Sponsors and Collaborators

  • Piccolo Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Piccolo Medical
ClinicalTrials.gov Identifier:
NCT05548192
Other Study ID Numbers:
  • CRD-15-325
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Sep 22, 2022