NCT02584673

Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Clear Guide Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-09
• Completion: 2016-12-09
• First posted: 2015-10-22
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study