SHERLOCK 3CG™ Diamond Tip Confirmation System

NCT03288766 | Terminated

• 1 other identifier: BAS-14-003
• Study Type: observational
• Target: 232
• Locations: 2 countries
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2

  Tip positioning is determined at bedside by the software via the Green Diamond Indicator (GDI+) and confirmed by CXR. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.

  The PICC insertion procedure is 60-90 mins in duration

Secondary Outcomes (2)

• Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI

  The PICC insertion procedure is 60-90 mins in duration

• Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist

  The PICC insertion procedure is 60-90 mins in duration

Study Arms (1)

PICC Placement with Study Device

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

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

Interventions

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

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.

PICC Placement with Study Device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be adult males or females ≥ 21 years of age with identifiable alterations of cardiac rhythm. For this study, altered cardiac rhythm is defined as any condition that does not have a P-wave on ECG.

You may qualify if:

• Male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable P-wave on standard ECG) with diagnosis of specific arrhythmia type or identification of pacemaker driven rhythms as defined below:
• Atrial fibrillation with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by study team RN at assessment, or
• All other arrhythmias (including but not limited to atrial flutter, PAC, PVC, PJC, tachycardia, AV Block, BB Block) with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by cardiac unit RN at assessment, or retrospectively by site cardiologist, or
• Pacemaker driven rhythm with temporary or permanent pacemaker device in place;
• Subject requires PICC placement as part of standard of care;
• Subject or Legally Authorized Representative (LAR) has signed an Informed Consent Form (ICF).

You may not qualify if:

• Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) to include:
• The presence of bacteremia or septicemia (known or suspected),
• The patient's body size is insufficient to accommodate the size of the implanted device,
• The patient is known or is suspected to be allergic to materials contained in the device,
• Past irradiation of prospective insertion site,
• Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
• Local tissue factors will prevent proper device stabilization and/or access;
• Subjects who previously had a PICC in place and require a PICC exchange;
• Subject has presence of active resting tremor (i.e. Parkinson's, Multiple Sclerosis, etc.) deemed by Investigator to have potential impact on procedure accuracy;
• Subjects who are pregnant or think they may be pregnant.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (8)

Summerlin Hospital and Medical Center

Las Vegas, Nevada, 89144, United States

Location

Moses Cone Hospital

Greensboro, North Carolina, 27401, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

J.W. Ruby Memorial Hospital

Morgantown, West Virginia, 26505, United States

Location

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

MeSH Terms

Conditions

Atrial Flutter; Atrial Premature Complexes; Ventricular Premature Complexes; Tachycardia; Atrioventricular Block; Bundle-Branch Block

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease; Heart Block

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Rushil Sankpal

  Becton Dickinson

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: April 19, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); AU (2)