Trials / Terminated
TerminatedNCT03288766
SHERLOCK 3CG™ Diamond Tip Confirmation System
A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 232 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is intended to confirm the accuracy of the SHERLOCK 3CG™ Diamond TCS with the addition of MODUS II (SLM2) software to eliminate the need for post-procedural chest x-ray (CXR) in adult subjects with cardiac abnormalities that alter presentation of the P-wave. Atrial fibrillation will be the primary target while data on pacemaker driven rhythms and other arrhythmia types will also be collected to explore overall performance.
Conditions
- Indication for Peripheral Intravenous Catheterization
- Atrial Flutter
- Premature Atrial Contraction
- Premature Ventricular Contraction
- Premature Junctional Contraction
- Tachycardia
- Atrioventricular Block
- Bundle-Branch Block
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-04-19
- Primary completion
- 2021-06-15
- Completion
- 2021-06-15
- First posted
- 2017-09-20
- Last updated
- 2021-10-20
Locations
8 sites across 2 countries: United States, Australia
Source: ClinicalTrials.gov record NCT03288766. Inclusion in this directory is not an endorsement.