Validation of AI Lumbar Spine Anatomy Measureing Function
Spinal cord
Functionality Assessment of RadiSpine, an Artificial Intelligence Software as Medical Device for Lumbar Spine Quantification System
1 other identifier
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedFirst Submitted
Initial submission to the registry
April 10, 2025
CompletedFirst Posted
Study publicly available on registry
April 30, 2025
CompletedApril 30, 2025
April 1, 2025
7 months
April 10, 2025
April 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Segmentation accuracy (Mean)
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
30 mins per individual
Secondary Outcomes (1)
Measurement accuracy
30 mins per individual
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- With history of spinal surgery
- Spinal trauma
- Spinal osteoporosis
- Spinal metastasis or infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RadiRad Co., Ltd.lead
- Taipei Veterans General Hospital, Taiwancollaborator
Study Sites (1)
Taipei Veterans General Hospital
Taipei, Taipei, 112, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2025
First Posted
April 30, 2025
Study Start
September 12, 2024
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
April 30, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share