ScanNav Anatomy PNB FDA Data Collection Plan

March 27, 2024 updated by: IntelligentUltrasound Limited

To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories:

  • Femoral Nerve (Femoral)
  • Interpectoral (PECS I) and pectoserratus (PECS II)
  • Transversus abdominis plane (TAP)
  • Serratus Plane (SP)
  • Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

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
    • California
      • San Diego, California, United States, 92108
        • Taylor Research

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Volunteers from the San Diego, California, USA region.

Description

Inclusion Criteria:

  • Male or female, at least 18 years of age;
  • Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

  • Aged <18 years of age;
  • Unwilling or unable to provide informed consent.
  • Previous history of medical interventions that may affect the anatomy of the chosen scan areas, e.g. hip replacements.

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
Intervention / Treatment
Volunteer Participants
Healthy adult (18+ years old) volunteers
Other: Ultrasound scans
Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound scan recordings
Time Frame: 6 months
Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.
6 months

Collaborators and Investigators

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

Sponsor

IntelligentUltrasound Limited

Investigators

  • Principal Investigator: James Bowness, Dr, Intelligent Ultrasound

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 1, 2023

Primary Completion (Actual)

July 21, 2023

Study Completion (Actual)

July 21, 2023

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IU2023_AG_12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Ultrasound Recordings

Clinical Trials on Ultrasound scans

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe