ScanNav Anatomy PNB Data Collection Study

March 27, 2024 updated by: IntelligentUltrasound Limited
Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.

Study Type

Observational

Enrollment (Actual)

82

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

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

Healthy adult volunteers.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Aged <18 years of age;
  2. Unwilling or unable to provide informed consent.

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
Volunteer participants being scanned by a qualified clinician using various ultrasound machines.
Other: N/A - non-interventional study
N/A - non-interventional study. Data collection only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training and/or validation data (in the form of recorded ultrasound scans)
Time Frame: 6 months
Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist 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

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)

March 22, 2023

Primary Completion (Actual)

May 12, 2023

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 15, 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_11

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.

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