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Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

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ClinicalTrials.gov Identifier: NCT02584673
Recruitment Status : Completed
First Posted : October 22, 2015
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
The Cooper Health System
Information provided by (Responsible Party):
Clear Guide Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Arterial and Midline Catheterization Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement
Study Start Date : October 2015
Actual Primary Completion Date : December 9, 2016
Actual Study Completion Date : December 9, 2016

Arm Intervention/treatment
Experimental: CAIG
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.
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.
Other Name: Clear Guide ONE

No Intervention: Control
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.



Primary Outcome Measures :
  1. Time Needed to Correctly Insert the Arterial or Midline Catheter. [ Time Frame: Immediately following intervention (within 2 hours) ]

Secondary Outcome Measures :
  1. Clinician Rating of the Device [ Time Frame: Immediately following intervention (within 2 hours) ]
  2. Number of Attempts [ Time Frame: Immediately following intervention (within 2 hours) ]
    Number of instrument pricks before target is reached

  3. Number of Times Needle Needs Repositioning [ Time Frame: Immediately following intervention (within 2 hours) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing vessel catheterization
  • Able to give written informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Prisoners, pregnant women, and children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584673


Locations
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United States, New Jersey
The Cooper Health System
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Clear Guide Medical
The Cooper Health System
Investigators
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Principal Investigator: Irwin Gratz, DO The Cooper Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clear Guide Medical
ClinicalTrials.gov Identifier: NCT02584673    
Other Study ID Numbers: CGM 15-001
First Posted: October 22, 2015    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes