Ultrasound Image Collection for the Development of an AI... | NCT06920277

Studies
Ultrasound Image Collection for the Development of an AI Software

NCT06920277

Sponsor

Smart Alfa Teknoloji San. ve Tic. A.S.

Status

Completed

Last Update Posted

Apr 9, 2025Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Ultrasound Scan

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

Apr 2025

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

Oct 29, 2024Actual

Primary Completion Date

Oct 31, 2024Actual

Completion Date

Oct 31, 2024Actual

First Submitted Date

Mar 25, 2025

First Submission Date that Met QC Criteria

Apr 2, 2025

First Posted Date

Apr 9, 2025Actual

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

Apr 2, 2025

Last Update Posted Date

Apr 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to collect ultrasound images from healthy volunteers in the U.S.

Detailed Description

The goal of this study is to create an ultrasound image dataset of healthy volunteers from the U.S. population. This dataset will be used for development of an AI software which will assist anesthesiologists in detection of key anatomical structures on the ultrasound image for peripheral nerve block applications. These blocks are:

Interscalene Brachial Plexus
Supraclavicular Brachial Plexus
Infraclavicular Brachial Plexus
Cervical Plexus
Axillary Brachial Plexus
PECS I & II
Transversus Abdominis Plane (TAP)
Rectus Sheath
Femoral Nerve
Adductor Canal
Popliteal Sciatic
Erector Spinae Plane (ESP)

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

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
U.S. population			Device: Ultrasound scans

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound scans	Device	10 seconds scanning for one block region	U.S. population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of ultrasound scan recordings relevant to peripheral nerve blocks collected	Ultrasound scans will be collected and reviewed for quality and completeness. The outcome will be the number of ultrasound recordings that meet predefined criteria for image quality; correct anatomical region and clear visualization to support AI development.	Day 1, 2 and 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed and dated informed consent form
At least 18 years of age and older
Stated willingness to comply with all study procedures and availability for the duration of the study
In good general health

Exclusion Criteria:

Pregnancy
Inability to lie to flat
Any complaint or anatomical deformity on the regions to be scanned

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 U.S. population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Senanur Samur Duysal	Smart Alfa Teknoloji San. ve Tic. A.S.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Conference Room at Doubletree by Hilton Austin		Austin	Texas	78752	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