PACMAN Ultrasound Recording Data Collection

September 18, 2019 updated by: Avanos Medical

Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development

Study to collect videos of ultrasound recordings during peripheral nerve block procedures.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

767

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Institute
      • Miami, Florida, United States, 33136
        • University of Miami
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Michigan
      • Troy, Michigan, United States, 48098
        • Universal Medical Resources
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota - Twin Cities
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with planned peripheral nerve block procedures.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Interscalene
Supraclavicular
Infraclavicular
Transversus Abdominus Plane
Paravertebral Space
Fascia Iliaca
Femoral Nerve
Saphenous Nerve via Adductor Canal
Popliteal Sciatic Nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of ultrasound recordings
Time Frame: 6 months
Collection of 100 ultrasound recordings for each group
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avanos Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 101-17-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia, Local

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe