ScanNav Anatomy PNB FDA Data Collection Plan

• Sponsor: IntelligentUltrasound Limited (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05963230
• Collaborator: (none)
• Enrollment: 40
• Anticipated Duration (Months): 5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Recordings	Other: Ultrasound scans

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: ScanNav Anatomy PNB FDA Data Collection Plan
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ultrasound scan recordings [6 months]

   Ultrasound scan recordings collected by experts in ultrasound-guided regional anaesthesia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• IntelligentUltrasound Limited

Investigators

• Principal Investigator: James Bowness, Dr, Intelligent Ultrasound

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IntelligentUltrasound Limited
• ClinicalTrials.gov Identifier: NCT05963230
• Other Study ID Numbers: IU2023_AG_12
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 27, 2023