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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas.
Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect.
The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy.
If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy assisted by GI-GENIUS | Experimental |
| |
| Standard colonoscopy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI-GENIUS Medtronic | Device | Colonoscopy assisted by GI-GENIUS device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of advanced lesions | To determine the impact of the GI-GENIUS device as an assistant to the endoscopist to detect advanced lesions (advanced adenomas and advanced serrated polyps) in FIT-based screening colonoscopies. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of other type of lesions | To determine the ability of the GI-GENIUS device to detect other lesions (colorectal cancer, adenomas, advanced adenomas, serrated polyps, advanced serrated polyps, non-polypoid lesions ≥10mm and right-sided advanced adenomas) | 15 months |
| Characteristics of GI-GENIUS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain | |||
| Hospital Clinic Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32267558 | Result | Aziz M, Fatima R, Dong C, Lee-Smith W, Nawras A. The impact of deep convolutional neural network-based artificial intelligence on colonoscopy outcomes: A systematic review with meta-analysis. J Gastroenterol Hepatol. 2020 Oct;35(10):1676-1683. doi: 10.1111/jgh.15070. Epub 2020 Apr 26. | |
| 29928897 | Result | Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18. |
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| Colonoscopy |
| Other |
Standard colonoscopy |
|
To describe the characteristics of using the GI-GENIUS device during a colonoscopy: withdrawal time, false-positive and false-negative rate of advanced lesions using the device, etc. |
| 1 month |
| Barcelona |
| Spain |
| Complexo Hospitalario de Ourense | Ourense | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital Universitario Río Hortega | Valladolid | Spain |
| Hospital Universitario Álvaro Cunqueiro | Vigo | Spain |
| 30814121 | Result | Wang P, Berzin TM, Glissen Brown JR, Bharadwaj S, Becq A, Xiao X, Liu P, Li L, Song Y, Zhang D, Li Y, Xu G, Tu M, Liu X. Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study. Gut. 2019 Oct;68(10):1813-1819. doi: 10.1136/gutjnl-2018-317500. Epub 2019 Feb 27. |
| 31981517 | Result | Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):343-351. doi: 10.1016/S2468-1253(19)30411-X. Epub 2020 Jan 22. |
| 37639723 | Derived | Mangas-Sanjuan C, de-Castro L, Cubiella J, Diez-Redondo P, Suarez A, Pellise M, Fernandez N, Zarraquinos S, Nunez-Rodriguez H, Alvarez-Garcia V, Ortiz O, Sala-Miquel N, Zapater P, Jover R; CADILLAC study investigators. Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias : A Randomized Trial. Ann Intern Med. 2023 Sep;176(9):1145-1152. doi: 10.7326/M22-2619. Epub 2023 Aug 29. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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