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Phase I completed. Phase II is cancelled.
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Phase I
Phase II
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sherlock 3CG | Experimental | 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. |
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| "Blind" Placement | Active Comparator | PICCs will be placed "blindly", without the use of any tip location/positioning device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sherlock 3CG | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG. | 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. | Time of PICC placement (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary. | Distance (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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon McLennan, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Phase I was feasibility and wasn't powered. Phase II was powered, but cancelled due to slow enrollment during Phase I.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects undergoing PICC placement for long term IV therapy
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG. | 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. | Posted | Mean | Standard Deviation | mm | Time of PICC placement (Day 0) |
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30 days following PICC placement procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sherlock 3CG | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extravasation | Surgical and medical procedures | Non-systematic Assessment | Subject had injection site extravasation. Subject recovered without sequelae. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Molotsky | Bard Access Systems, Inc. | 856-266-1327 | sharon.molotsky@crbard.com |
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| Blind Placement | Other | PICCs will be placed "blindly", without the use of any tip location/positioning device. |
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| Day 0 |
| Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement | Proportion 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. | Day 0 |
| 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. | Measurements (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. | Day 0 |
| Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side. | Mean 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. | Day 0 |
| Inability to achieve maximum p-wave |
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| years |
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| Gender | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Reason For PICC Placement | Number | participants |
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| Access Vein | Number | participants |
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| Access Side | Number | participants |
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| Participants |
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| Secondary | Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary. | Distance (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. | Posted | Mean | Standard Deviation | mm | Day 0 |
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| Secondary | Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement | Proportion 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. | Posted | Number | participants | Day 0 |
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| Secondary | 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. | Measurements (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. | Posted | Mean | Standard Deviation | mm | Day 0 |
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| Secondary | Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side. | Mean 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. | Posted | Mean | Standard Deviation | mm | Day 0 |
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| 0 |
| 27 |
| 1 |
| 27 |
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