No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC PlacementSTAT-PICCNCT01275430
Assessment of the Precision of the Sherlock 3CG Tip Positioning System
A study testing Sherlock 3CG and Blind Placement in people with No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement, run by C. R. Bard at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement
- What is being tested?
- Sherlock 3CG and Blind Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 21years
- Require 5 F dual lumen or 4 F single lumen PowerPICC or PowerPICC SOLO placement as part of standard care
- Be able to undergo study procedures
- Subject is able to comply with all study requirements and be available for 30 day follow-up visit.
- Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative
Who cannot join
- Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) (See Section 18.2)
- Subject has been previously randomized for this study.
- Subject is unable to lie in the supine position on the fluoroscopy table
- Subject had radiation therapy within the last three years
- Subject has an existing pregnancy
- Subject has known glomerular filtration rate (GFR) <45 ml/min/1.73m2
Show all 16Show fewer
- Subject has a functioning pacemaker or defibrillator
- Subject has an artificial heart or heart transplant
- Subject has anatomical abnormalities of the central venous system
- Subject has atrial fibrillation or other atrial arrhythmias in which a p-wave was not consistently present on ECG
- Subject has internal wires that may interfere with imaging
- Subject has an existing central venous catheter
- Subject is unable to raise arms above the head while lying down.
- Subject has a BMI ≥45
- The clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.
- Subject has a known allergy or hypersensitivity to contrast media.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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:
- 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.
- the movement of the cardiovascular anatomy, if any, when the arm is adducted from above the head to the side of the subject.
- 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
- Being tested
- Sherlock 3CG, Blind Placement
- Keywords
- central venous catheters, peripherally inserted central catheters (PICC_, Electrocardiography (ECG), intravascular ECG, Tip Positioning System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sherlock 3CGDevice
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.
Blind PlacementOther
PICCs will be placed "blindly", without the use of any tip location/positioning device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sherlock 3CG |
| "Blind" Placement | Active comparator | PICCs will be placed "blindly", without the use of any tip location/positioning device. Receives: Other: Blind Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time of PICC placement (Day 0)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Phase I completed. Phase II is cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC PlacementStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon McLennan, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275430
- Sponsor's protocol ID
- BAS-3004
- Acronym
- STAT-PICC
- Status last verified
- Nov 2016
- First submitted
- 11 Jan 2011
- Last updated
- 16 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Phase I was feasibility and wasn't powered. Phase II was powered, but cancelled due to slow enrollment during Phase I.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01275430
- Acronym / sponsor ID
- STAT-PICC / BAS-3004
- Conditions
- No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement
- Keywords
- central venous catheters, peripherally inserted central catheters (PICC_, Electrocardiography (ECG), intravascular ECG, Tip Positioning System
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase I completed. Phase II is cancelled.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Posted 4 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- the movement of the cardiovascular anatomy, if any, when the arm is adducted from above the head to the side of the subject.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sherlock 3CG | Experimental | Device: Sherlock 3CGSherlock 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. |
| "Blind" Placement | Active comparator | Other: Blind PlacementPICCs will be placed "blindly", without the use of any tip location/positioning device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age ≥ 21years
- Require 5 F dual lumen or 4 F single lumen PowerPICC or PowerPICC SOLO placement as part of standard care
- Be able to undergo study procedures
- Subject is able to comply with all study requirements and be available for 30 day follow-up visit.
- Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative
Key exclusion criteria (16 listed)
- Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) (See Section 18.2)
- Subject has been previously randomized for this study.
- Subject is unable to lie in the supine position on the fluoroscopy table
- Subject had radiation therapy within the last three years
- Subject has an existing pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sherlock 3CGSherlock 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. | Device | Sherlock 3CG |
| Blind PlacementPICCs will be placed "blindly", without the use of any tip location/positioning device. | Other | "Blind" Placement |
Primary outcome
Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.
Time frame: 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.
4 secondary outcomes
Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.
Time frame: Day 0
Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement
Time frame: 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.
Time frame: 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.
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Phase I was feasibility and wasn't powered. Phase II was powered, but cancelled due to slow enrollment during Phase I.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon McLennan, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sherlock 3CG and Blind Placement in people with No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement, run by C. R. Bard at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG. (time frame: Time of PICC placement (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.