Study Stopped
Interim Goals met. Decision made to terminate in favor of completing the study as a second protocol in the future.
PACMAN Ultrasound Recording Data Collection
Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development
1 other identifier
observational
767
1 country
8
Brief Summary
Study to collect videos of ultrasound recordings during peripheral nerve block procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2017
CompletedFirst Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2019
CompletedSeptember 19, 2019
September 1, 2019
2.1 years
December 6, 2017
September 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Collection of ultrasound recordings
Collection of 100 ultrasound recordings for each group
6 months
Study Arms (9)
Interscalene
Supraclavicular
Infraclavicular
Transversus Abdominus Plane
Paravertebral Space
Fascia Iliaca
Femoral Nerve
Saphenous Nerve via Adductor Canal
Popliteal Sciatic Nerve
Eligibility Criteria
Subjects with planned peripheral nerve block procedures.
You may qualify if:
- Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block
- Informed consent executed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avanos Medicallead
Study Sites (8)
George Washington University
Washington D.C., District of Columbia, 20037, United States
Andrews Institute
Gulf Breeze, Florida, 32561, United States
University of Miami
Miami, Florida, 33136, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Universal Medical Resources
Troy, Michigan, 48098, United States
University of Minnesota - Twin Cities
Minneapolis, Minnesota, 55455, United States
Duke University
Durham, North Carolina, 27710, United States
Christ Hospital
Cincinnati, Ohio, 45245, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 11, 2017
Study Start
July 31, 2017
Primary Completion
September 17, 2019
Study Completion
September 17, 2019
Last Updated
September 19, 2019
Record last verified: 2019-09