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OpenTrials
Completed

NCT Number: NCT05784935

Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions

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

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AIG Hospitals

Hyderabad, Telangana, 500032, India

About this study

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 After cecal intubation is performed, the colonoscope will be slowly withdrawn to the splenic flexure by the primary endoscopists.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing colonoscopy of age 18 to 80 years.
  • 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
  • Consecutive adult patients scheduled to undergo routine colonoscopy at AIG

Exclusion criteria

  • Females who are pregnant
  • Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator
  • Recent colonoscopy within past 12 month
  • History of inflammatory bowel disease
  • History of colorectal cancer
  • Previous bowel resection (apart from appendectomy)
  • Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
  • Bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.

Treatment and study plan

Real time AI detection model

Device

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

Primary outcomes

  1. Performance of a novel state-of-the-art Artificial Intelligence model (AI-Model) for colorectal lesion detection during routine diagnostic colonoscopy

    Time frame: 1 Year

    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.

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: iIDEAS/RTD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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