Indication for Peripheral Intravenous CatheterizationMODUSNCT03028090
Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System
An observational study of Indication for Peripheral Intravenous Catheterization, run by C. R. Bard at 2 sites in United States.
Trial summary
This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central catheter (PICC) tip confirmation technology. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Indication for Peripheral Intravenous Catheterization
- What is being tested?
- SHERLOCK 3CG™ Tip Confirmation System with MODUS Software
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Nov 2014
- 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: The study population was to be comprised of a sufficient number of subjects so that a minimum of 201 subjects completed the study, but no more than 250 subjects were to be enrolled.
Who may be able to join
- A subject must have met the following criteria to be enrolled in the study:
- Male or female, age ≥ 21 years
- Subject required PICC placement as part of standard of care
- Subject had signed an Informed Consent Form (ICF) or had an ICF signed by the subject's legally authorized representative
Who cannot join
- A subject was excluded if any of the following criteria were met:
- Subject had a contraindication to PICC placement as listed in the Instructions for Use (IFU)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Health System
Colorado Springs, Colorado, 80909
Bethesda North Hospital
Montgomery, Ohio, 45242
About this study
Official title: A Two-Arm Prospective, Multi-Centered Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System
This study was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central catheter (PICC) tip confirmation technology. The study was to promote the development of a software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform. All study participants received PICCs as their standard of care.
Read the detailed description
The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients.
In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. developed a software package, MODUS, which can accurately define the maximum p-wave on an ECG waveform. This software provides visual and/or audio queues to notify the PICC placer of the location of the tip of the PICC relative to the cavoatrial junction of the patient.
Subjects who required bedside PICC placement as standard of care and met eligibility criteria were enrolled. The software package was not used in the guidance or placement of the PICC tip. PICCs were placed per standard of care procedure using anthropometric measurements with the SHERLOCK 3CG™ TCS System. Data from the placements was sent back to Bard for analysis.
- Being tested
- SHERLOCK 3CG™ Tip Confirmation System with MODUS Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHERLOCK 3CG™ Tip Confirmation System with MODUS SoftwareDevice
The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. is developing MODUS, a software package.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion
The measurement used will be percent agreement between clinician and MODUS software. Agreement of 95% between the nurse clinician and software assessments will be used to validate the study hypothesis.
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 posted23 Jan 2017 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
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
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Gilbert, BSN, Study director, CR Bard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028090
- Sponsor's protocol ID
- BAS-13-001
- Acronym
- MODUS
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm Prospective, Multi-Centered Study to Assess Electrocardiogram Waveforms Produced Through the Utilization of the Sherlock 3CG™ Tip Confirmation System
- ClinicalTrials.gov ID
- NCT03028090
- Acronym / sponsor ID
- MODUS / BAS-13-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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 was to gather real-time ECG data through the use of the SHERLOCK 3CG™ Tip Confirmation System (TCS), an electrocardiogram (ECG)-based peripherally-inserted central catheter (PICC) tip confirmation technology. The study was to promote the development of a software package (MODUS) that can accurately define the maximum P-wave on an ECG waveform. All study participants received PICCs as their standard of care.
Detailed description
The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients.
In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. developed a software package, MODUS, which can accurately define the maximum p-wave on an ECG waveform. This software provides visual and/or audio queues to notify the PICC placer of the location of the tip of the PICC relative to the cavoatrial junction of the patient.
Subjects who required bedside PICC placement as standard of care and met eligibility criteria were enrolled. The software package was not used in the guidance or placement of the PICC tip. PICCs were placed per standard of care procedure using anthropometric measurements with the SHERLOCK 3CG™ TCS System. Data from the placements was sent back to Bard for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was to be comprised of a sufficient number of subjects so that a minimum of 201 subjects completed the study, but no more than 250 subjects were to be enrolled.
Key inclusion criteria (4 listed)
- Male or female, age ≥ 21 years
- Subject required PICC placement as part of standard of care
- Subject had signed an Informed Consent Form (ICF) or had an ICF signed by the subject's legally authorized representative
Key exclusion criteria (2 listed)
- A subject was excluded if any of the following criteria were met:
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 3CG™ Tip Confirmation System with MODUS SoftwareThe SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. is developing MODUS, a software package. | Device | – |
Primary outcome
Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion
Time frame: The PICC insertion procedure is 60-90 mins in duration
The measurement used will be percent agreement between clinician and MODUS software. Agreement of 95% between the nurse clinician and software assessments will be used to validate the study hypothesis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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.
Gina Gilbert, BSN study director
CR Bard
2 sites in 1 country: 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, run by C. R. Bard at 2 sites 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent agreement between maximum P-wave assessments of PICC nurse clinicians and the MODUS software during PICC insertion (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 23 Jan 2017.