Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 8 for:    clear guide medical

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614222
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : June 14, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
The Cooper Health System
Information provided by (Responsible Party):
Clear Guide Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Blocks Device: Peripheral Nerve Blocks with CAIG Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks
Study Start Date : October 26, 2015
Actual Primary Completion Date : May 25, 2016
Actual Study Completion Date : May 25, 2016

Arm Intervention/treatment
Experimental: Peripheral Nerve Block with CAIG
The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
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.
Other Name: Clear Guide ONE

No Intervention: Peripheral Nerve Block without CAIG
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.



Primary Outcome Measures :
  1. Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block [ Time Frame: Immediately after intervention (within 2 hours) ]

Secondary Outcome Measures :
  1. Clinician Rating of the Device [ Time Frame: Immediately following intervention (within 2 hours) ]
    Clinician rates the device on a scale of 1-10. This also includes a questionnaire.

  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) ]
  4. Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire [ Time Frame: Post-op day 1 ]
    Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.

  5. Number of Patients That Needed Rescue Opioids [ Time Frame: During hospital stay (maximum 3 days) ]
  6. Incidence of Postoperative Nausea and Vomiting [ Time Frame: During hospital stay (maximum 3 days) ]
    Number of participants that reported postoperative nausea and vomiting

  7. Undesired Muscle Weakness Measured Subjectively [ Time Frame: During hospital stay (maximum 3 days) ]
    Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
  • Able to give written informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Patients in whom regional anesthesia is contradicted

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): NCT02614222


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Ronak Desai, DO The Cooper Health System
Layout table for additonal information
Responsible Party: Clear Guide Medical
ClinicalTrials.gov Identifier: NCT02614222    
Other Study ID Numbers: CGM 15-002
First Posted: November 25, 2015    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: July 7, 2017
Last Verified: June 2017
Keywords provided by Clear Guide Medical:
Computer Assisted Instrument Guidance (CAIG)
Peripheral Nerve Block
Clear Guide ONE
Needle path
Needle Guidance
Ultrasound