Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

• Sponsor: Clear Guide Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02584673
• Collaborator: The Cooper Health System (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 14.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.	N/A

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

• Study Type: Interventional
• 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: Oct 1, 2015
• Actual Primary Completion Date: Dec 9, 2016
• Actual Study Completion Date: Dec 9, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Clinician Rating of the Device [Immediately following intervention (within 2 hours)]

2. Number of Attempts [Immediately following intervention (within 2 hours)]

   Number of instrument pricks before target is reached

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing vessel catheterization

• Able to give written informed consent

Exclusion Criteria:

• Unable to give informed consent

• Prisoners, pregnant women, and children

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cooper Health System	Camden	New Jersey	United States	08103

Sponsors and Collaborators

• Clear Guide Medical
• The Cooper Health System

Investigators

• Principal Investigator: Irwin Gratz, DO, The Cooper Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clear Guide Medical
• ClinicalTrials.gov Identifier: NCT02584673
• Other Study ID Numbers: CGM 15-001
• First Posted: Oct 22, 2015
• Last Update Posted: Jun 14, 2017
• Last Verified: May 1, 2017

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

Study Results

Participant Flow

Arm/Group Title	CAIG	Control
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.	The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CAIG	Control	Total
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.	The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.	Total of all reporting groups
Overall Participants	15	15	30
Age, Customized (Count of Participants)
Count of Participants [Participants]	0 0%
Sex/Gender, Customized (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Time Needed to Correctly Insert the Arterial or Midline Catheter.
Time Frame	Immediately following intervention (within 2 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CAIG	Control
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.	The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
Measure Participants	15	15
Mean (Standard Deviation) [Seconds]	30.07 (28.63)	44.76 (33.96)

2. Secondary Outcome

Title	Clinician Rating of the Device
Time Frame	Immediately following intervention (within 2 hours)

Outcome Measure Data

Analysis Population Description

This data was not collected

Arm/Group Title	CAIG	Control
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.	The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
Measure Participants	0	0

3. Secondary Outcome

Title	Number of Attempts
Description	Number of instrument pricks before target is reached
Time Frame	Immediately following intervention (within 2 hours)

Outcome Measure Data

Analysis Population Description

This data was not collected

Arm/Group Title	CAIG	Control
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.	The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
Measure Participants	0	0

4. Secondary Outcome

Title	Number of Times Needle Needs Repositioning
Time Frame	Immediately following intervention (within 2 hours)

Outcome Measure Data

Analysis Population Description

This data was not collected

Arm/Group Title	CAIG	Control
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.	The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
Measure Participants	0	0

Adverse Events

Arm/Group Title	CAIG		Control
Arm/Group Description	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. 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.		The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
All Cause Mortality
	CAIG		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CAIG		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	CAIG		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.