Artificial IntelligenceiIDEAS/RTDNCT05784935
Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions
An observational study of Artificial Intelligence and Colonic Polyp, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence, Colonic Polyp
- What is being tested?
- Real time AI detection model
- Type of treatment
- Medical device
- How many people
- 380 participants
- Where
- 1 siteIndia
- Study dates
- 20 Mar 2023to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Artificial Intelligence, Colonic Polyp
- Being tested
- Real time AI detection model
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time AI detection modelDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start20 Mar 2023
- Primary completion1 Jul 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Artificial IntelligenceStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hardik Rughwani, MD, DM, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784935
- Sponsor's protocol ID
- iIDEAS/RTD
- Acronym
- iIDEAS/RTD
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rughwani H, Garg R, Memon SF, Yeung CK, Sreedhar B, Lai KP, Patel R, Jagtap N, Hussain SJ, Sanny M, Kalapala R, Reddy DN. Real-Time AI-Assisted Detection of Colonic Lesions Using the iIDEAS Intelligent-C Module: A Prospective Single-Center Validation Study. JGH Open. 2026 Sep 17;10(9):e70470. doi: 10.1002/jgh3.70470. eCollection 2026 Sep.
PubMed 42761157
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIDEAS Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions - a Prospective, Single Blinded, Non - Randomized, Single - Center Study
- ClinicalTrials.gov ID
- NCT05784935
- Acronym / sponsor ID
- iIDEAS/RTD / iIDEAS/RTD
- Conditions
- Artificial Intelligence, Colonic Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real time AI detection modelBowel 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 | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 42761157Rughwani H, Garg R, Memon SF, Yeung CK, Sreedhar B, Lai KP, Patel R, Jagtap N, Hussain SJ, Sanny M, Kalapala R, Reddy DN. Real-Time AI-Assisted Detection of Colonic Lesions Using the iIDEAS Intelligent-C Module: A Prospective Single-Center Validation Study. JGH Open. 2026 Sep 17;10(9):e70470. doi: 10.1002/jgh3.70470. eCollection 2026 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hardik Rughwani, MD, DM principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligence and Colonic Polyp, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.