No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02498821 -
Time and Motion Related to PICC Insertion Process and Catheter Tip Confirmation
|
N/A |