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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05784935
Other study ID # iIDEAS/RTD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 20, 2023
Est. completion date November 1, 2023

Study information

Verified date March 2023
Source Asian Institute of Gastroenterology, India
Contact Hardik Rughwani, MD, DM
Phone 9426928600
Email hardik.hr@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To conduct an single blinded, non-randomized, prospective, single center trial to validate the performance of a novel state-of-the-art Artificial Intelligence model (AI-Model) for colorectal lesion detection during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Consecutive patients referred for a screening, surveillance or diagnostic colonoscopy will be included


Description:

All procedures will be performed with high-definition endoscopes; Bowel preparation will be conducted according to usual local practices. During colonoscopy, the colonoscope will be first advanced to the cecum in all patients as confirmed by identification of the appendicular orifice and ileocecal valve or by intubation of the ileum, as per the standard of care by experienced endoscopists. During the insertion, no action will be taken. After cecal intubation is performed, the colonoscope will be slowly withdrawn to the splenic flexure by the primary endoscopists. Real time AI detection model will be activated with the output displayed in real time on a separate monitor and will be only viewed by an independent investigator, who is an experienced endoscopists (or a person trained in polyp recognition). The primary endoscopists will be blinded to the AI real time detection result All detected polyps will be removed or with biopsy taken during this examination and sent for histopathology examination.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 380
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients undergoing colonoscopy of age 18 to 80 years. 2. Patient who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure 3. Consecutive adult patients scheduled to undergo routine colonoscopy at AIG Exclusion Criteria: 1. Females who are pregnant 2. Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator 3. Recent colonoscopy within past 12 month 4. History of inflammatory bowel disease 5. History of colorectal cancer 6. Previous bowel resection (apart from appendectomy) 7. Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes 8. Bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Real time AI detection model
Bowel preparation will be conducted according to usual local practices. During colonoscopy, the colonoscope will be first advanced to the cecum in all patients as confirmed by identification of the appendicular orifice and ileocecal valve or by intubation of the ileum, as per the standard of care by experienced endoscopists. During the insertion, no action will be taken. After cecal intubation is performed, the colonoscope will be slowly withdrawn to the splenic flexure by the primary endoscopists. Real time AI detection model will be activated with the output displayed in real time on a separate monitor and will be only viewed by an independent investigator, who is an experienced endoscopists (or a person trained in polyp recognition). The primary endoscopists will be blinded to the AI real time detection result

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Asian Institute of Gastroenterology, India

Outcome

Type Measure Description Time frame Safety issue
Primary Performance of a novel state-of-the-art Artificial Intelligence model (AI-Model) for colorectal lesion detection during routine diagnostic colonoscopy A single-blinded, non-randomized prospective trial to validate the performance of a novel state-of-the-art Artificial Intelligence model (AI-Model) for colorectal lesion detection during routine diagnostic colonoscopy. 1 Year
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