Clinical trial · Interventional
Computer Aided Detection of Polyps in the Colon
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to examine the role of an automatic polyp detection software (henceforth referred to as the research software) as a support system during colonoscopy; a procedure during which a physician uses a colonoscope or scope, to look inside a patient's rectum and colon. The scope is a flexible tube with a camera-to see the lining of the colon. The research software is used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. The research software used in this study was programmed by a company in Shanghai, which develops artificial intelligence software for computer aided diagnostics. The research software was developed using a large repository (database or databases) of polyp images where expert colonoscopists outlined polyps and suspicious lesions. The software was subsequently developed and validated using several databases of images and video to operate in near real-time or within minutes of photographing the tissue. It is intended to point out polyps and suspicious lesions on a separate screen that stands behind the primary monitor during colonoscopy. It is not expected to change the colonoscopy procedure in any way, and the physician will make the final determination on whether or not to biopsy or remove any lesion in the colon wall. The research software will not record any video data during the colonoscopy procedure. In the future, this software may help gastroenterologists detect precancerous areas and decrease the incidence of colon cancer in the United States.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Polyp, Adenomatous | Adenomatous Polyp | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer Aided Diagnostic Software | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm-1 Standard Colonoscopy/AI-Assisted Combined Colonoscopy
- description
- Normal scope insertion and withdrawal first, followed by a second withdrawal with the research software running on a separate screen to catch any additional polyps missed during the first withdrawal.
- interventionNames
- Device: Computer Aided Diagnostic Software
- type
- EXPERIMENTAL
- label
- Arm-2 AI-Assisted Combined Colonoscopy/Standard Colonoscopy
- description
- Normal scope insertion but first withdrawal with the research software running on a separate screen, followed by a second withdrawal without the research software running.
- interventionNames
- Device: Computer Aided Diagnostic Software
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age: ≥ 22 years * Patients presenting for routine colonoscopy for screening and/or surveillance purposes. * Willingness to undergo two withdrawals with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation * Ability to provide written, informed consent and understand the responsibilities of trial participation Exclusion Criteria: * Minors aged \< 22 years. * People with diminished cognitive capacity * Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active gastrointestinal bleed, referring collectively to the stomach and the small and large intestine). * Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation) * Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation). * Patients with inflammatory bowel disease * Patients with any polypoid/ulcerated lesion \> 2 cm concerning for invasive cancer on endoscopy * Patients referred for endoscopic mucosal resection (EMR), which is a procedure to remove early-stage cancer and precancerous growths from the lining of the digestive tract.
References
Publications (7)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
- BACKGROUNDWinawer SJ, Fletcher RH, Miller L, Godlee F, Stolar MH, Mulrow CD, Woolf SH, Glick SN, Ganiats TG, Bond JH, Rosen L, Zapka JG, Olsen SJ, Giardiello FM, Sisk JE, Van Antwerp R, Brown-Davis C, Marciniak DA, Mayer RJ. Colorectal cancer screening: clinical guidelines and rationale. Gastroenterology. 1997 Feb;112(2):594-642. doi: 10.1053/gast.1997.v112.agast970594. No abstract available. PMID 9024315
- BACKGROUNDFerlitsch M, Reinhart K, Pramhas S, Wiener C, Gal O, Bannert C, Hassler M, Kozbial K, Dunkler D, Trauner M, Weiss W. Sex-specific prevalence of adenomas, advanced adenomas, and colorectal cancer in individuals undergoing screening colonoscopy. JAMA. 2011 Sep 28;306(12):1352-8. doi: 10.1001/jama.2011.1362. PMID 21954479
- BACKGROUNDWinawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701. PMID 8247072
- BACKGROUNDRex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available. PMID 25448873
- BACKGROUNDCorley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086. PMID 24693890
- Glissen Brown JR, Mansour NM, Wang P, Chuchuca MA, Minchenberg SB, Chandnani M, Liu L, Gross SA, Sengupta N, Berzin TM. Deep Learning Computer-aided Polyp Detection Reduces Adenoma Miss Rate: A United States Multi-center Randomized Tandem Colonoscopy Study (CADeT-CS Trial). Clin Gastroenterol Hepatol. 2022 Jul;20(7):1499-1507.e4. doi: 10.1016/j.cgh.2021.09.009. Epub 2021 Sep 14.