Validation of AI Lumbar Spine Anatomy Measureing Function

NCT ID: NCT06950411

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-12

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Compression

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

1. With history of spinal surgery
2. Spinal trauma
3. Spinal osteoporosis
4. Spinal metastasis or infection
Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

RadiRad Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Validation of Spinal Anatomy

Identifier Type: -

Identifier Source: org_study_id

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