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OpenTrials
Completed

NCT Number: NCT06950411

Validation of AI Lumbar Spine Anatomy Measureing Function

Spinal degeneration and its associated clinical diseases are common ailments in aging societies. With the advent of a super-aging society, the importance of assistive technologies for spinal image interpretation is increasingly significant to enhance care efficiency and reduce medical personnel expenditure. Recently, due to the rapid development of artificial intelligence (AI) algorithm, AI-based computer-assisted detection (CADe) devices gradiually become a convenient method for spinal anatomy measurement. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiSpine (an application program) in spinal anatomy segmentation and measurement.

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Key information

Conditions

Spinal Cord Compression Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Wounds and Injuries

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

The subjects should be aged 20 or older and younger than 75, with an equal gender distribution of 50% male and 50% female. From this group, 150 subjects with reasonable datavalues will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

Exclusion criteria

  • With history of spinal surgery
  • Spinal trauma
  • Spinal osteoporosis
  • Spinal metastasis or infection

Treatment and study plan

Primary outcomes

  1. Segmentation accuracy (Mean)

    Time frame: 30 mins per individual

    The minimum Mean Dice Coefficient (MDC), defined as the lower limit of the 95% confidence interval (CI) for MDC, is above a predetermined allowable limit equal to 0.8

Secondary outcomes

  1. Measurement accuracy

    Time frame: 30 mins per individual

    The maximum Mean Absolute Error (MAE), defined as the upper limit of the 95% CI for MAE, is below a predetermined allowable error limit equal to 2 mm

Sponsors and collaborators

Lead sponsor

RadiRad Co., Ltd.

Industry

Collaborators

  • Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

Functionality Assessment of RadiSpine, an Artificial Intelligence Software as Medical Device for Lumbar Spine Quantification System

Acronym: Spinal cord

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

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.

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