Assessment of the Precision of the Sherlock 3CG Tip Positioning System

Stopped early · Not applicable

Conditions studied: No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement

In brief

Phase I * determine the location of the peripherally inserted central catheter (PICC) tip upon observation of maximum p-wave amplitude Phase II * determine the precision of PICC placement in the Sherlock 3CG group versus the standard PICC placement

Key facts

Study ID

NCT01275430

Run by

C. R. Bard

People needed

27

Starts

2011-01-01

Expected to finish

2012-03-01

Last updated by the study team

2016-11-16

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age ≥ 21years
• Require 5 F dual lumen or 4 F single lumen PowerPICC or PowerPICC SOLO placement as part of standard care
• Be able to undergo study procedures
• Subject is able to comply with all study requirements and be available for 30 day follow-up visit.
• Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative

You may not qualify if…

• Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) (See Section 18.2)
• Subject has been previously randomized for this study.
• Subject is unable to lie in the supine position on the fluoroscopy table
• Subject had radiation therapy within the last three years
• Subject has an existing pregnancy
• Subject has known glomerular filtration rate (GFR) <45 ml/min/1.73m2
• Subject has a functioning pacemaker or defibrillator
• Subject has an artificial heart or heart transplant
• Subject has anatomical abnormalities of the central venous system
• Subject has atrial fibrillation or other atrial arrhythmias in which a p-wave was not consistently present on ECG
• Subject has internal wires that may interfere with imaging
• Subject has an existing central venous catheter
• Subject is unable to raise arms above the head while lying down.
• Subject has a BMI ≥45
• The clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.
• Subject has a known allergy or hypersensitivity to contrast media.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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