Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05139186
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2021-11-18
Brief Title:
The EYE Study Enhancing the Diagnostic Yield of Standard Colonoscopy by Artificial Intelligence Aided Endoscopy
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
The EYE Study Enhancing the Diagnostic Yield of Standard Colonoscopy by Artificial Intelligence Aided Endoscopy
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
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:
EYE
Brief Summary:
Colorectal cancer CRC remains one of the leading causes of mortality among neoplastic diseases in the world1 Adequate colonoscopy based CRC screening programs have proved to be the key to reduce the risk of mortality by early diagnosis of existing CRC and detection of pre-cancerous lesions2-4 Nevertheless long-term effectiveness of colonoscopy is influenced by a range of variables that make it far from a perfect tool5 The effectiveness of a colonoscopy mainly depends on its quality which in turn is dependent on the skill and expertise of the endoscopist In fact several studies have shown a significant adenoma miss rate of 24-35 especially in patients with diminutive adenomas67 These data are in line with interval cancers incidence I-CRC defined as the percentage of cancers diagnosed after a screening program and before the intended surveillance duration of approximately 3-5 89
The development of the artificial intelligence AI applications in the medical field has grown in interest in the past decade Its performance on increasing automatic polyp and adenoma detection has shown promising results in order to achieve an higher ADR10 The use of computer aided diagnosis CAD for detection of polyps had initially been studied in ex vivo studies but in the last few years with the advancement in computer aided technology and emergence of deep learning algorithms use of AI during colonoscopy has been achieved and more studies have been undertaken 10
Recently Fujifilm Tokyo Japan has developed a new technology known as CAD-EYE aiming to support both colonic polyp detection and characterization during colonoscopy This technology is now available in Europe being compatible with the latest generation of Fujifilm endoscopes ELUXEO Fujifilm Co
However the clinical impact of CAD-EYE system in improving the adenoma detection have yet to be assessed
The development of the artificial intelligence AI applications in the medical field has grown in interest in the past decade Its performance on increasing automatic polyp and adenoma detection has shown promising results in order to achieve an higher ADR10 The use of computer aided diagnosis CAD for detection of polyps had initially been studied in ex vivo studies but in the last few years with the advancement in computer aided technology and emergence of deep learning algorithms use of AI during colonoscopy has been achieved and more studies have been undertaken 10
Recently Fujifilm Tokyo Japan has developed a new technology known as CAD-EYE aiming to support both colonic polyp detection and characterization during colonoscopy This technology is now available in Europe being compatible with the latest generation of Fujifilm endoscopes ELUXEO Fujifilm Co
However the clinical impact of CAD-EYE system in improving the adenoma detection have yet to be assessed
Detailed Description:
None
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