ScanNav Anatomy PNB FDA Data Collection Plan | NCT05963230

Studies
ScanNav Anatomy PNB FDA Data Collection Plan

NCT05963230

Sponsor

IntelligentUltrasound Limited

Status

Completed

Last Update Posted

Mar 28, 2024Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Ultrasound Recordings

Interventions

Ultrasound scans

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Jul 21, 2023Actual

Completion Date

Jul 21, 2023Actual

First Submitted Date

Jul 19, 2023

First Submission Date that Met QC Criteria

Jul 19, 2023

First Posted Date

Jul 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2024

Last Update Posted Date

Mar 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Volunteer Participants		Healthy adult (18+ years old) volunteers	Other: Ultrasound scans

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound scans	Other	Ultrasound scans collected by experts in ultrasound-guided regional anaesthesia.	Volunteer Participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Volunteers from the San Diego, California, USA region.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Bowness, Dr	Intelligent Ultrasound	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taylor Research		San Diego	California	92108	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided