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

A Study to Assess the Precision of the Sherlock 3CG Tip Positioning System as a Tool to Guide Peripherally Inserted Central Catheter Placement

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

The feasibility phase of this study (Phase I) is a prospective, single arm, single-center feasibility study to determine the distance of the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave after PICC tip placement using the Sherlock 3CG system. Subjects judged by site personnel to require PICC placement will be screened against the study inclusion/exclusion criteria. Those subjects meeting the study criteria will be offered enrollment into the study. Informed consent will be obtained prior to subject enrollment.

PICC nurses who have been fully trained in the correct use of the Sherlock 3CG Tip Positioning System will perform the PICC placement procedures in the fluoroscopy suite. Serious adverse events (SAEs) will be collected, but collection of non-serious AEs will be limited to those adverse events (AEs) considered to be study procedure and/or device-related.

Subject follow up will be complete 30 days following the date of the study PICC procedure.

The results of the feasibility phase will be used to determine:

1. the distance, if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in the pivotal phase of the study (See Section 3.5.3), in order to have the PICC tip at the upper cavoatrial junction.
2. the movement of the cardiovascular anatomy, if any, when the arm is adducted from above the head to the side of the subject.
3. the movement of the PICC tip when the arm is moved from the 90° angle to the side.

Phase II (Pivotal) will not begin until the Phase I (feasibility) is complete. The Phase II study is a prospective, single-center, controlled, blinded, randomized study to compare the Sherlock 3CG as a tool in guiding PICC placement to the standard "blind" technique (control). Subjects judged by site personnel to require PICC placement will be screened against the study inclusion/exclusion criteria. Those subjects meeting the study criteria will be offered participation into the study. Informed consent will be obtained prior to subject enrollment. Subjects will be randomly assigned to either the Sherlock 3CG group or the control group in a 1:1 fashion. Due to the different placement techniques being utilized, the PICC nurses and study coordinator will not be blinded to the study device. PICC nurses who have been fully trained in the correct use of the Sherlock 3CG will perform the PICC placement procedures in the fluoroscopy suite. Serious adverse events (SAEs) will be collected, but collection of non-serious AEs will be limited to those AEs considered to be study procedure and/or device-related. Subject follow up will be complete 30 days following the date of the study PICC procedure.

Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination. Phase II was cancelled.

Inclusion Criteria:

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

Exclusion Criteria:

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