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

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.

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Key information

Conditions

Ultrasound Imaging of Anatomical Structures Nerve Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University School of Medicine

Ankara, 06230, Turkey (Türkiye)

About this study

Ultrasound-guided nerve and plane blocks have facilitated regional anesthesia by providing clinicians with real-time imaging capabilities for precise needle placement and application of local anesthetics. These techniques involve the use of ultrasound technology to visualize nerves and surrounding anatomical structures, allowing for accurate identification and targeting of specific nerve pathways. Additionally, the integration of artificial intelligence (AI) into ultrasound-guided nerve blocks offers further enhancements to this practice. AI algorithms can assist clinicians in image interpretation, needle localization, and decision-making, streamlining procedural workflows and reducing the risk of complications. The sponsor, Smart Alfa Teknoloji San. Ve Tic. A.Ş., located in Ankara, Turkey, aims to collect data from planned regions of volunteers to develop artificial intelligence-supported nerve block software (Nerveblox). The gathered data will be utilized for training, validation, and test processes of the AI algorithm.

The study methodology encompasses the following components:

A cohort of 200 volunteers, evenly distributed by gender (100 male, 100 female), will have their demographic data (BMI, gender, age) documented.
Each scan from one volunteer is expected to take 30 minutes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound scans

Other

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

Primary outcomes

Assessment of image quality

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

Ankara University

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Apr 19, 2024
Registry last updated: Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed