Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software

NCT06375603 | Completed

• 1 other identifier: SMARTALPHA-NERVEBLOX-1001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices.

Conditions

Ultrasound Imaging of Anatomical Structures; Nerve Block

Keywords

Ultrasound Imaging; Artificial Intelligence; Nerve Block

Outcome Measures

Primary Outcomes (1)

• Assessment of image quality

  Collected images will be used for labeling anatomical landmarks for development of Nerveblox.

  6 months

Interventions

Ultrasound scans OTHER

Clinical experts will conduct non-invasive ultrasound scans from the specified nerve or plane block views and record the acquired data.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 healthy volunteers will participate in the data collection study. Their weight, height, age, and gender information will be documented.

You may qualify if:

• Male at least 18 years of age
• Female at least 18 years of age
• Health volunteers
• Able to confirm and sign the Informed Consent Form before enrolment the study

You may not qualify if:

• Male below 18 years of age
• Female below 18 years of age
• Unwilling to participate or unable to sign an informed consent form
• Inability to lie flat
• Anatomical deformity in the area to be scanned for nerve and plane blocks

Sponsors & Collaborators

• Smart Alfa Teknoloji San. ve Tic. A.S.: lead
• Ankara University: collaborator

Study Sites (1)

Ankara University School of Medicine

Ankara, 06230, Turkey (Türkiye)

Location

Study Officials

• Süheyla Karadağ Erkoç, Assoc. Prof.

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: December 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)