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

NCT ID: NCT06375603

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-05-01

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.

Detailed 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.

Conditions

Ultrasound Imaging of Anatomical Structures; Nerve Block

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound scans

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Süheyla Karadağ Erkoç, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

Ankara University School of Medicine

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SMARTALPHA-NERVEBLOX-1001

Identifier Type: -

Identifier Source: org_study_id