NCT01275430

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Sherlock 3CG	Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
OTHER	Blind Placement	PICCs will be placed "blindly", without the use of any tip location/positioning device.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-01-12
• Last updated: 2016-11-16
• Results posted: 2016-07-04

Locations

1 site across 1 country: United States