ClinicalTrials.gg
CompletedNCT06950411Spinal cordUpdated Apr 30, 2025

Validation of AI Lumbar Spine Anatomy Measureing Function

An observational study in Spinal Cord Compression, sponsored by RadiRad Co., Ltd.. Completed at 1 site in Taiwan. Open to participants aged 22 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by RadiRad Co., Ltd. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
150
Ages
22 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Spinal Cord Compression

Keywords

  • Artificial Intelligence(AI) Algorithm Spinal anatomy
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In context

Spinal Cord Compression

52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.

This study's enrollment of 150 is above the median of 70 across 17 observational studies indexed under Spinal Cord Compression.

Browse Spinal Cord Compression studies →

Lead sponsor

RadiRad Co., Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. With history of spinal surgery
  2. Spinal trauma
  3. Spinal osteoporosis
  4. Spinal or infection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: 30 mins per individual

Secondary outcomes

  1. Measurement accuracy

    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

    Time frame: 30 mins per individual

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Study locations

1 site
  • Taipei Veterans General Hospital
    Taipei, 112, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2024 to primary completion in Mar 2025, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2025
First posted
Apr 30, 2025
StartActual
Sep 12, 2024
Primary completionActual
Mar 31, 2025
CompletionActual
Mar 31, 2025
Last update
Apr 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06950411
Lead sponsor
RadiRad Co., Ltd.
Responsible party
Sponsor
First posted
Apr 30, 2025
Start date
Sep 12, 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Last update
Apr 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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