Arterial and Midline CatheterizationNCT02584673
Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
A study testing Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities. in people with Arterial and Midline Catheterization, run by Clear Guide Medical at 1 site in United States.
Trial summary
The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial and Midline Catheterization
- What is being tested?
- Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 9 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing vessel catheterization
- Able to give written informed consent
Who cannot join
- Unable to give informed consent
- Prisoners, pregnant women, and children
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.
Read the detailed description
The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.
- Conditions
- Arterial and Midline Catheterization
- Being tested
- Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.Device
Also called Clear Guide ONE
The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.
| Study group | Role | What they receive |
|---|---|---|
| CAIG | Experimental | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Receives: Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities. |
| Control | No intervention | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Needed to Correctly Insert the Arterial or Midline Catheter.
Measured: Immediately following intervention (within 2 hours)
Secondary outcomes (3)
Clinician Rating of the Device
Measured: Immediately following intervention (within 2 hours)
Number of Attempts
Number of instrument pricks before target is reached
Measured: Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning
Measured: Immediately following intervention (within 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial and Midline 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Guide Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cooper Health System
- Responsible party
- Sponsor
- Investigators
- Irwin Gratz, DO, Principal investigator, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584673
- Sponsor's protocol ID
- CGM 15-001
- Status last verified
- May 2017
- First submitted
- 21 Oct 2015
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
- ClinicalTrials.gov ID
- NCT02584673
- Acronym / sponsor ID
- CGM 15-001
- Conditions
- Arterial and Midline Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clear Guide MedicalIndustry (pharma, biotech, devices)
- Collaborators
- The Cooper Health System
- Study start
- Oct 2015
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.
Detailed description
The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAIG | Experimental | Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. |
| Control | No intervention | –The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing vessel catheterization
- Able to give written informed consent
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Prisoners, pregnant women, and children
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 |
|---|---|---|
| Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.Also: Clear Guide ONEThe Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. | Device | CAIG |
Primary outcome
Time Needed to Correctly Insert the Arterial or Midline Catheter.
Time frame: Immediately following intervention (within 2 hours)
3 secondary outcomes
Clinician Rating of the Device
Time frame: Immediately following intervention (within 2 hours)
Number of Attempts
Time frame: Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning
Time frame: Immediately following intervention (within 2 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Related trials for Arterial and Midline Catheterization
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Application of Intermittent Training in Radial Artery Puncture and Catheterization Skills Under Ultrasound-Guided Line Guidance
Learning and Memorization of Radial Artery Puncture and Catheterization Guided by Ultrasound Midline
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.
Irwin Gratz, DO principal investigator
The Cooper Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities. in people with Arterial and Midline Catheterization, run by Clear Guide Medical 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 2 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 14 Jun 2017. 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 14 Jun 2017). 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?
Time Needed to Correctly Insert the Arterial or Midline Catheter. (time frame: Immediately following intervention (within 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02584673, which also lists 1 linked publication.
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 14 Jun 2017.