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NCT03368976 Clinical Trial

PACMAN Ultrasound Recording Data Collection

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03368976
Other study ID # 101-17-0001
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 31, 2017
Est. completion date September 17, 2019

Study information
Verified date September 2019
Source Avanos Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 767
Est. completion date September 17, 2019
Est. primary completion date September 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Christ Hospital Cincinnati Ohio
United States Duke University Durham North Carolina
United States Andrews Institute Gulf Breeze Florida
United States Indiana University Indianapolis Indiana
United States University of Miami Miami Florida
United States University of Minnesota - Twin Cities Minneapolis Minnesota
United States Universal Medical Resources Troy Michigan
United States George Washington University Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Avanos Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collection of ultrasound recordings Collection of 100 ultrasound recordings for each group 6 months
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