Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449742
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-04
Brief Title:
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be conducted as a monocentric observational retrospective and prospective case- control study design
Detailed Description:
This monocentric retrospective and prospective observational study wants to evaluate the diagnostic performances in identifying vertebral fractures of an artificial intelligence tool compared to radiologist in standard chest-abdomen CT scans performed for other indications than osteo-metabolic disease
The UO of Endocrinology in collaboration with the UO of Radiology of the IRCCS San Raffaele Hospital proposes to assess the prevalence of vertebral fractures retrospectively and prospectively in the population afferent to our hospital a level 3 diagnostic centre to perform abdomen-chest CT studies in the year 2024 period 01012024-31122024 through the application of the AI software NanoxAIHealthVCF NANO-X IMAGING LTD
The specific population to be examined will be male patients over 50 years of age who perform an abdomen-chest CT examination at our center for clinical indications unrelated to osteometabolic diseases
The UO of Endocrinology in collaboration with the UO of Radiology of the IRCCS San Raffaele Hospital proposes to assess the prevalence of vertebral fractures retrospectively and prospectively in the population afferent to our hospital a level 3 diagnostic centre to perform abdomen-chest CT studies in the year 2024 period 01012024-31122024 through the application of the AI software NanoxAIHealthVCF NANO-X IMAGING LTD
The specific population to be examined will be male patients over 50 years of age who perform an abdomen-chest CT examination at our center for clinical indications unrelated to osteometabolic diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None