Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 5:34 PM
Study NCT ID:
NCT04915833
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer-aided Detection During Screening Colonoscopy (Experts)
Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Organization:
Study Overview
Official Title:
Real-time Computer-aided Polyp Detection During Screening Colonoscopy Performed by Expert Endoscopists
Status:
UNKNOWN
Status Verified Date:
2022-03
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:
None
Brief Summary:
Evaluation of the colonic mucosa with a high definition colonoscope (EPKi7010 video processor).
The endoscopy images will be seen on a 27inch, flat-panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) only by one expert endoscopist, randomly assigned.
The number, location, and polyps' features (Paris classification) will be recorded by the operator. If a polyp is detected, the endoscopist will remove the polyp endoscopically with a cold snare.
The same patient will be submitted to a second, the same session, computed aided real-time colonoscopy using the DISCOVERY, AI-assisted polyp detector. Colonoscopy will be performed by a same-level-of-expertise operator in comparison to the initial procedure. Any polyp or lesion detected with the AI system will be recorded and endoscopically removed and considered as a missed lesion from standard colonoscopy.
The endoscopy images will be seen on a 27inch, flat-panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) only by one expert endoscopist, randomly assigned.
The number, location, and polyps' features (Paris classification) will be recorded by the operator. If a polyp is detected, the endoscopist will remove the polyp endoscopically with a cold snare.
The same patient will be submitted to a second, the same session, computed aided real-time colonoscopy using the DISCOVERY, AI-assisted polyp detector. Colonoscopy will be performed by a same-level-of-expertise operator in comparison to the initial procedure. Any polyp or lesion detected with the AI system will be recorded and endoscopically removed and considered as a missed lesion from standard colonoscopy.
Detailed Description:
Screening colonoscopy has decreased the incidence of colorectal carcinoma in the previous decades. However, there are reports of missed polyps and interval CRC following screening colonoscopy. Several factors may affect the ADR, PDR, and missed lesions rates, such as bowel preparation, percentage of mucosal surface evaluation, and the training levels of operators.
Artificial intelligence using deep-learning algorithms has been implemented in gastrointestinal endoscopy, mainly for the detection and diagnosis of GI tract lesions such as colonic polyps and adenomas. The implementation of automated polyp detection software during screening colonoscopy may prevent the missing of polyp and adenoma during screening colonoscopy. Therefore, improving the ADR and PDR during colonoscopies. All of this, with the aim of decrease the incidence of interval colorectal carcinoma (CRC), and CRC-related morbidity and mortality.
The Discovery Artificial Intelligence assisted polyp detector (Pentax Medical, Hoya Group) was recently launched for clinical practice. This AI software was trained with 120,000 files from approximately 300 clinical cases. The visual aided detection (bounding box locating a polyp on the monitor) will alert the endoscopist if a polyp/adenoma was missed during the standard, screening procedure.
To the best of our knowledge, this may be the first study evaluating the Discovery AI-assisted polyp detector on clinical practice in the western hemisphere. The investigators aim to evaluate the real-world effectiveness of AI-assisted colonoscopy in clinical practice. The investigators will also evaluate the role of endoscopists' levels of training in the ADR, PDR, and missed lesion rate.
Artificial intelligence using deep-learning algorithms has been implemented in gastrointestinal endoscopy, mainly for the detection and diagnosis of GI tract lesions such as colonic polyps and adenomas. The implementation of automated polyp detection software during screening colonoscopy may prevent the missing of polyp and adenoma during screening colonoscopy. Therefore, improving the ADR and PDR during colonoscopies. All of this, with the aim of decrease the incidence of interval colorectal carcinoma (CRC), and CRC-related morbidity and mortality.
The Discovery Artificial Intelligence assisted polyp detector (Pentax Medical, Hoya Group) was recently launched for clinical practice. This AI software was trained with 120,000 files from approximately 300 clinical cases. The visual aided detection (bounding box locating a polyp on the monitor) will alert the endoscopist if a polyp/adenoma was missed during the standard, screening procedure.
To the best of our knowledge, this may be the first study evaluating the Discovery AI-assisted polyp detector on clinical practice in the western hemisphere. The investigators aim to evaluate the real-world effectiveness of AI-assisted colonoscopy in clinical practice. The investigators will also evaluate the role of endoscopists' levels of training in the ADR, PDR, and missed lesion rate.
Study Oversight
Has Oversight DMC:
True
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?: