NCT02614222

Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks

Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Clear Guide Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.

Detailed description

This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized 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.

Conditions

• Peripheral Nerve Blocks

Interventions

Type	Name	Description
DEVICE	Peripheral Nerve Blocks with CAIG	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: 2015-10-26
• Primary completion: 2016-05-25
• Completion: 2016-05-25
• First posted: 2015-11-25
• Last updated: 2017-07-07
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States