Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions (iIDEAS/RTD)

IIDEAS Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions - a Prospective, Single Blinded, Non - Randomized, Single - Center Study

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

Study Overview

• Status: Completed
• Conditions: Colonic Polyp; Artificial Intelligence
• Intervention / Treatment: Device: Real time AI detection model

Detailed 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 After cecal intubation is performed, the colonoscope will be slowly withdrawn to the splenic flexure by the primary endoscopists.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.

• Study Type: Observational
• Enrollment (Actual): 380

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • AIG Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Our pilot series showed AI assistance can detect up to 80 % of missed lesions with sample variance at around 0.032. We hypothesize that the adenoma/polyp miss rate of conventional colonoscopy can be reduced by 50% to 75% with AI assistance. Assuming 4% patients may be excluded. The sample size is estimated to be 381 patients in total with a power of 95% and a significance level of 0.05.

An interim analysis will be performed when the first 150 patients are recruited to verify the sample size estimation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Hardik Rughwani, MD, DM, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: iIDEAS/RTD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No