Indication for Peripheral Intravenous CatheterizationMODUS IINCT03288766
SHERLOCK 3CG™ Diamond Tip Confirmation System
An observational study of Indication for Peripheral Intravenous Catheterization and Atrial Flutter, run by C. R. Bard at 8 sites in 2 countries.
Trial summary
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Indication for Peripheral Intravenous Catheterization, Atrial Flutter, Premature Atrial Contraction
- What is being tested?
- PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
- Type of treatment
- Surgery or procedure
- How many people
- 232 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 19 Apr 2018to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects will be adult males or females ≥ 21 years of age with identifiable alterations of cardiac rhythm. For this study, altered cardiac rhythm is defined as any condition that does not have a P-wave on ECG.
Who may be able to join
- Male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable P-wave on standard ECG) with diagnosis of specific arrhythmia type or identification of pacemaker driven rhythms as defined below:
- Atrial fibrillation with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by study team RN at assessment, or
- All other arrhythmias (including but not limited to atrial flutter, PAC, PVC, PJC, tachycardia, AV Block, BB Block) with history of diagnosis per 12-lead ECG in medical record or diagnosed via bedside telemetry by cardiac unit RN at assessment, or retrospectively by site cardiologist, or
- Pacemaker driven rhythm with temporary or permanent pacemaker device in place;
- Subject requires PICC placement as part of standard of care;
- Subject or Legally Authorized Representative (LAR) has signed an Informed Consent Form (ICF).
Who cannot join
- Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) to include:
- The presence of bacteremia or septicemia (known or suspected),
- The patient's body size is insufficient to accommodate the size of the implanted device,
- The patient is known or is suspected to be allergic to materials contained in the device,
- Past irradiation of prospective insertion site,
- Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site,
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- Local tissue factors will prevent proper device stabilization and/or access;
- Subjects who previously had a PICC in place and require a PICC exchange;
- Subject has presence of active resting tremor (i.e. Parkinson's, Multiple Sclerosis, etc.) deemed by Investigator to have potential impact on procedure accuracy;
- Subjects who are pregnant or think they may be pregnant.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Moses Cone Hospital
Greensboro, North Carolina, 27401
Vidant Medical Center
Greenville, North Carolina, 27834
Summerlin Hospital and Medical Center
Las Vegas, Nevada, 89144
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, 26505
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Australia2 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
About this study
Official title: A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.
Read the detailed description
This study is intended to confirm the accuracy of the SHERLOCK 3CG™ Diamond TCS with the addition of MODUS II (SLM2) software to eliminate the need for post-procedural chest x-ray (CXR) in adult subjects with cardiac abnormalities that alter presentation of the P-wave. Atrial fibrillation will be the primary target while data on pacemaker driven rhythms and other arrhythmia types will also be collected to explore overall performance.
- Conditions
- Indication for Peripheral Intravenous Catheterization, Atrial Flutter, Premature Atrial Contraction, Premature Ventricular Contraction, Premature Junctional Contraction, Tachycardia
- Being tested
- PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
- Medical subject headings
- Atrial Flutter, Atrial Premature Complexes, Ventricular Premature Complexes, Tachycardia, Atrioventricular Block, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II softwareProcedure or surgery
The SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient.
| Study group | Role | What they receive |
|---|---|---|
| PICC Placement with Study Device | PICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software Receives: Procedure: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
Tip positioning is determined at bedside by the software via the Green Diamond Indicator (GDI+) and confirmed by CXR. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.
Measured: The PICC insertion procedure is 60-90 mins in duration
Secondary outcomes (2)
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI
It is expected there will be some cases where the MODUS II software may fail to present a Green Diamond Indicator (GDI-). In the absence of a GDI, tip positioning is determined at bedside using magnetic tracking and external measurement per hospital protocol, with CXR required for tip confirmation. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.
Measured: The PICC insertion procedure is 60-90 mins in duration
Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist
An independent, blinded radiologist will judge PICC tip position retrospectively against pre-specified anatomical criteria compared with findings of the SLM2.
Measured: The PICC insertion procedure is 60-90 mins in duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start19 Apr 2018
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Peripheral Intravenous CatheterizationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rushil Sankpal, Study director, Becton Dickinson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288766
- Sponsor's protocol ID
- BAS-14-003
- Acronym
- MODUS II
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2017
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Prospective, Multi-Centered Study to Assess the SHERLOCK 3CG™ Diamond Tip Confirmation System
- ClinicalTrials.gov ID
- NCT03288766
- Acronym / sponsor ID
- MODUS II / BAS-14-003
- Conditions
- Indication for Peripheral Intravenous Catheterization, Atrial Flutter, Premature Atrial Contraction, Premature Ventricular Contraction, Premature Junctional Contraction, Tachycardia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 232 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally inserted central catheters (PICCs) in adult subjects with altered cardiac rhythm.
Detailed description
This study is intended to confirm the accuracy of the SHERLOCK 3CG™ Diamond TCS with the addition of MODUS II (SLM2) software to eliminate the need for post-procedural chest x-ray (CXR) in adult subjects with cardiac abnormalities that alter presentation of the P-wave. Atrial fibrillation will be the primary target while data on pacemaker driven rhythms and other arrhythmia types will also be collected to explore overall performance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICC Placement with Study Device | – | Procedure: PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II softwarePICC Placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be adult males or females ≥ 21 years of age with identifiable alterations of cardiac rhythm. For this study, altered cardiac rhythm is defined as any condition that does not have a P-wave on ECG.
Key inclusion criteria (6 listed)
- Male or female, ≥ 21 years of age with altered cardiac rhythm (no recognizable P-wave on standard ECG) with diagnosis of specific arrhythmia type or identification of pacemaker driven rhythms as defined below:
- Subject requires PICC placement as part of standard of care;
- Subject or Legally Authorized Representative (LAR) has signed an Informed Consent Form (ICF).
Key exclusion criteria (10 listed)
- Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) to include:
- Subjects who previously had a PICC in place and require a PICC exchange;
- Subject has presence of active resting tremor (i.e. Parkinson's, Multiple Sclerosis, etc.) deemed by Investigator to have potential impact on procedure accuracy;
- Subjects who are pregnant or think they may be pregnant.
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 |
|---|---|---|
| PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II softwareThe SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) is an FDA-cleared fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology, indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients without any alterations of cardiac rhythms that change the normal presentation of the P-wave. A software package, MODUS II, has been developed to accurately analyze the entire ECG complex and identify the correct placement of the PICC tip based on a patient's individual ECG, in the absence of an easily identifiable P-wave. This software system is designed to provide visual and/or audio cues to notify the PICC placer of the location of the PICC tip relative to the cavoatrial junction (CAJ) of the patient. | Procedure or surgery | PICC Placement with Study Device |
Primary outcome
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2
Time frame: The PICC insertion procedure is 60-90 mins in duration
Tip positioning is determined at bedside by the software via the Green Diamond Indicator (GDI+) and confirmed by CXR. PICC tip placement will be considered successful if it is determined to be in the lower 1/3 of the SVC or in the CAJ by an independent, blinded radiologist judging position retrospectively against pre-specified anatomical criteria.
2 secondary outcomes
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 in the absence of a GDI
Time frame: The PICC insertion procedure is 60-90 mins in duration
Percent agreement between the site readings of the CXR (standard of care) versus those completed by an independent, blinded radiologist
Time frame: The PICC insertion procedure is 60-90 mins in duration
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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.
Rushil Sankpal study director
Becton Dickinson
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for Peripheral Intravenous Catheterization and Atrial Flutter, run by C. R. Bard at 8 sites in 2 countries.
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 6 inclusion and 10 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. 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?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Rate of successful PICC tip placement within the lower third of the superior vena cava (SVC) or in the cavoatrial junction (CAJ) using SLM2 (time frame: The PICC insertion procedure is 60-90 mins in duration). 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 20 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.