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PACMAN Ultrasound Recording Data Collection

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: NCT03368976
Recruitment Status : Terminated (Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.)
First Posted : December 11, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Avanos Medical

Study Description
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Brief Summary:
Study to collect videos of ultrasound recordings during peripheral nerve block procedures.

Condition or disease
Anesthesia, Local

Study Design
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Study Type : Observational
Actual Enrollment : 767 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : September 17, 2019
Groups and Cohorts
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Group/Cohort
Interscalene
Supraclavicular
Infraclavicular
Transversus Abdominus Plane
Paravertebral Space
Fascia Iliaca
Femoral Nerve
Saphenous Nerve via Adductor Canal
Popliteal Sciatic Nerve


Outcome Measures
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Primary Outcome Measures :
  1. Collection of ultrasound recordings [ Time Frame: 6 months ]
    Collection of 100 ultrasound recordings for each group


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with planned peripheral nerve block procedures.
Criteria

Inclusion Criteria:

  • Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
  • Informed consent executed

Exclusion Criteria:

  • Patients unable to understand and provide written consent
  • Infection at the injection site
  • Allergy to local anesthetic agents
  • Medical condition obscuring visualization
  • Known neuropathy at or around target nerve for the PNB
  • Inability to communicate with the investigator or hospital staff
Contacts and Locations
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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): NCT03368976


Locations
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United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Andrews Institute
Gulf Breeze, Florida, United States, 32561
University of Miami
Miami, Florida, United States, 33136
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Universal Medical Resources
Troy, Michigan, United States, 48098
United States, Minnesota
University of Minnesota - Twin Cities
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Christ Hospital
Cincinnati, Ohio, United States, 45245
Sponsors and Collaborators
Avanos Medical
More Information
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Responsible Party: Avanos Medical
ClinicalTrials.gov Identifier: NCT03368976    
Other Study ID Numbers: 101-17-0001
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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