Trial Outcomes & Findings for Assessment of the Precision of the Sherlock 3CG Tip Positioning System (NCT NCT01275430)
NCT ID: NCT01275430
Last Updated: 2016-11-16
Results Overview
Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
TERMINATED
NA
27 participants
Time of PICC placement (Day 0)
2016-11-16
Participant Flow
Participant milestones
| Measure |
Sherlock 3CG
Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.
All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants.
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|---|---|
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Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Sherlock 3CG
Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.
All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
No Contrast Injection
|
6
|
|
Overall Study
Device Malfunction
|
1
|
|
Overall Study
Inability to achieve maximum p-wave
|
1
|
Baseline Characteristics
Assessment of the Precision of the Sherlock 3CG Tip Positioning System
Baseline characteristics by cohort
| Measure |
Sherlock 3CG
n=18 Participants
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.
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.
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|---|---|
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Age, Continuous
|
52.7 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
|
Gender
Female
|
6 Participants
n=99 Participants
|
|
Gender
Male
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
17 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
|
Reason For PICC Placement
Antibiotics
|
17 participants
n=99 Participants
|
|
Reason For PICC Placement
Total Parenteral Nutrition (TPN)
|
1 participants
n=99 Participants
|
|
Access Vein
Brachial
|
9 participants
n=99 Participants
|
|
Access Vein
Basilic
|
9 participants
n=99 Participants
|
|
Access Side
Left
|
6 participants
n=99 Participants
|
|
Access Side
Right
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Time of PICC placement (Day 0)Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Outcome measures
| Measure |
Sherlock 3CG
n=18 Participants
Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
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|---|---|
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Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.
PICC tip above upper CAJ
|
18.8 mm
Standard Deviation 18.1
|
|
Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.
PICC tip below upper CAJ
|
14.3 mm
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Day 0Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Outcome measures
| Measure |
Sherlock 3CG
n=18 Participants
Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
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|---|---|
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Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.
|
13.8 mm
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: Day 0Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed. Note - this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Outcome measures
| Measure |
Sherlock 3CG
n=18 Participants
Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
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|---|---|
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Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement
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18 participants
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SECONDARY outcome
Timeframe: Day 0Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°). All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Outcome measures
| Measure |
Sherlock 3CG
n=18 Participants
Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
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|---|---|
|
Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject's Side.
|
0 mm
Standard Deviation 0
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SECONDARY outcome
Timeframe: Day 0Mean distance (mm) of PICC tip movement when the subject's arm is adducted from a 90° position to the subject's side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side . All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Outcome measures
| Measure |
Sherlock 3CG
n=18 Participants
Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
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|---|---|
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Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side.
PICC tip moved caudally
|
22.3 mm
Standard Deviation 12.0
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Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side.
PICC tip moved cephalad
|
8.7 mm
Standard Deviation 7.0
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Adverse Events
Sherlock 3CG
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sherlock 3CG
n=27 participants at risk
Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
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|---|---|
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Surgical and medical procedures
Extravasation
|
3.7%
1/27 • 30 days following PICC placement procedure
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place