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SHERLOCK 3CG™ Diamond Tip Confirmation System

NCT03288766 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 232

Last updated 2021-10-20

No results posted yet for this study

Summary

This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.

Conditions

  • Indication for Peripheral Intravenous Catheterization
  • Atrial Flutter
  • Premature Atrial Contraction
  • Premature Ventricular Contraction
  • Premature Junctional Contraction
  • Tachycardia
  • Atrioventricular Block
  • Bundle-Branch Block

Interventions

PROCEDURE

PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software

The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Rushil Sankpal · Becton Dickinson

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2021-06-15
Completion
2021-06-15

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288766 on ClinicalTrials.gov