Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
232 participants
OBSERVATIONAL
2018-04-19
2021-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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PICC Placement with Study Device
PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. 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
2. 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
3. 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).
Exclusion Criteria
1. The presence of bacteremia or septicemia (known or suspected),
2. The patient's body size is insufficient to accommodate the size of the implanted device,
3. The patient is known or is suspected to be allergic to materials contained in the device,
4. Past irradiation of prospective insertion site,
5. Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
6. 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.
21 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Rushil Sankpal
Role: STUDY_DIRECTOR
Becton Dickinson
Locations
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Summerlin Hospital and Medical Center
Las Vegas, Nevada, United States
Moses Cone Hospital
Greensboro, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, United States
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Countries
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Other Identifiers
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BAS-14-003
Identifier Type: -
Identifier Source: org_study_id