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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06375603
• Other study ID #: SMARTALPHA-NERVEBLOX-1001
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2024
• Source: Smart Alfa Teknoloji San. ve Tic. A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Ultrasound Imaging of Anatomical Structures

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Smart Alfa Teknoloji San. ve Tic. A.S.	Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of image quality	Collected images will be used for labeling anatomical landmarks for development of Nerveblox.	6 months