ScanNav Anatomy PNB Data Collection Study

Completed

• Conditions: Data Collection
• Interventions: Other: N/A - non-interventional study

• Registration Number: NCT05992805
• Lead Sponsor: IntelligentUltrasound Limited

Brief Summary

Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.

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 Timeline

• Study Start: 2023-03-22
• Study First Submitted: 2023-03-27
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-12
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Volunteer Participants	N/A - non-interventional study	Volunteer participants being scanned by a qualified clinician using various ultrasound machines.

Primary Outcome Measures

Name	Time	Method
Training and/or validation data (in the form of recorded ultrasound scans)	6 months	Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist ultrasound-guided regional anaesthesia.

Trial Locations

Locations (1)

Hodge House; 🇬🇧 Cardiff, United Kingdom