Colorectal CancerNCT05513261
Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3
A study testing High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate and PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate in people with Colorectal Cancer, run by Fundacin Biomedica Galicia Sur at 3 sites in Spain.
Trial summary
This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate and PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 857 participants
- Where
- 3 sitesSpain
- Study dates
- 17 Nov 2023to 14 May 2024
- Phase
- Interventional
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.
- Surveillance after resection of colorectal adenomas
- Acceptance after reading the information sheet and signing informed consent.
Who cannot join
- Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments).
- Incomplete colonoscopy without cecal intubation.
- Previous CRC
- Previous colonic resection.
- Hereditary CRC syndromes
- Serrated polyposis syndrome
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Complexo Hospitalario Universitario de Ourense
Ourense, Ourense, 32003.
Hospital de Montecelo
Pontevedra, Pontevedra
Hospital Álvaro Cunqueiro (Vigo)
Vigo, Pontevedra
About this study
Official title: PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.
This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).
Read the detailed description
Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC, can reduce CRC incidence and mortality. Adenoma Detection Rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality.
Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE (NBI International Colorectal Endoscopic) Classification has proposed use high definition endoscopes that have Narrow Band Imaging (NBI). However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary.
Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, the CAD system aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion.
PolyDeep CAD is a functional prototype. This CAD system is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated. The aim of PolyDeep advance 3 is to compare Adenoma Detection Rate differences in a randomized clinical trial. The investigators will compare the Adenoma Detection Rate between high definition colonoscopy and PolyDeep assisted high definition colonoscopy, both in CRC screening and surveillance.
- Conditions
- Colorectal Cancer
- Being tested
- High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate, PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate
- Keywords
- Colorectal adenomas, Colorectal polyps, Serrated lesions, Polydeep, computer-aided System
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition colonoscopy (standard colonoscopy) in Adenoma Detection RateDiagnostic test
In the intervention of this arm the investigators will apply the standard colonoscopy without computer-aided colonoscopy (polyDeep)
PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection RateDiagnostic test
In the intervention of this arm the investigators will apply polyDeep assisted high definition colonoscopy (CAD system).
| Study group | Role | What they receive |
|---|---|---|
| Control arm: High definition colonoscopy | Other | Diagnostic test: Standard colonoscopy Receives: Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate |
| PolyDeep assisted high definition colonoscopy | Experimental | Diagnostic test: PolyDeep Receives: Diagnostic Test: PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Number of colonoscopies with adenomas/total number of colonoscopies. The investigators will evaluate if there are differences between both arms.
Measured: 1.5 years
Secondary outcomes (5)
Polyp detection rate
Number of colonoscopies with polyps/total number of colonoscopies. The investigators will evaluate if there are differences between both arms.
Measured: 1.5 years
Serrated lesion detection rate
Number of colonoscopies with serrated lesions/total number of colonoscopies. The investigators will evaluate if there are differences between both arms.
Measured: 1.5 years
Advanced lesion detection rate
Number of colonoscopies with advanced lesions (adenomas≥10mm, villous histology or high grade dysplasia; serrated lesions with dysplasia or ≥10mm) /total number of colonoscopies. The investigators will evaluate if there are differences between both arms.
Measured: 1.5 years
Withdrawal time:
Withdrawal time between the two arms will be calculated and compared by the investigators
Measured: 1.5 years
Characterization of the detected lesions.
The investigators will evaluate the optical diagnosis accuracy of Polydeep for the final histological diagnosis (sensitivity, specificity, positive and negative predictive values).
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start17 Nov 2023
- Primary completion8 Mar 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who fulfill criteria will be randomly allocated to high definition colonoscopy or Polydeep assisted high definition colonoscopy.
- Masking
- None (open label)
- Enrolment
- 857 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, Ministry of Work and Welfare - Xunta de Galicia, Asociación Española de Gastroenterología, European Regional Development Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513261
- Sponsor's protocol ID
- PolyDeep Advance 3.0
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are not a plan to make Individual Participant Data (IPD)
Publications
Cubiella J, Marzo-Castillejo M, Mascort-Roca JJ, Amador-Romero FJ, Bellas-Beceiro B, Clofent-Vilaplana J, Carballal S, Ferrandiz-Santos J, Gimeno-Garcia AZ, Jover R, Mangas-Sanjuan C, Moreira L, Pellise M, Quintero E, Rodriguez-Camacho E, Vega-Villaamil P; Sociedad Espanola de Medicina de Familia y Comunitaria y Asociacion Espanola de Gastroenterologia. Clinical practice guideline. Diagnosis and prevention of colorectal cancer. 2018 Update. Gastroenterol Hepatol. 2018 Nov;41(9):585-596. doi: 10.1016/j.gastrohep.2018.07.012. Epub 2018 Sep 20. English, Spanish.
PubMed 30245076Corley 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.
PubMed 24693890Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
PubMed 30738046Liu A, Wang H, Lin Y, Fu L, Liu Y, Yan S, Chen H. Gastrointestinal endoscopy nurse assistance during colonoscopy and polyp detection: A PRISMA-compliant meta-analysis of randomized control trials. Medicine (Baltimore). 2020 Aug 21;99(34):e21278. doi: 10.1097/MD.0000000000021278.
PubMed 32846754ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
PubMed 25597420Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
PubMed 30296432Jin EH, Lee D, Bae JH, Kang HY, Kwak MS, Seo JY, Yang JI, Yang SY, Lim SH, Yim JY, Lim JH, Chung GE, Chung SJ, Choi JM, Han YM, Kang SJ, Lee J, Chan Kim H, Kim JS. Improved Accuracy in Optical Diagnosis of Colorectal Polyps Using Convolutional Neural Networks with Visual Explanations. Gastroenterology. 2020 Jun;158(8):2169-2179.e8. doi: 10.1053/j.gastro.2020.02.036. Epub 2020 Feb 29.
PubMed 32119927Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.
PubMed 32598963Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
PubMed 26782820Wani S, Rastogi A. Narrow-band imaging in the prediction of submucosal invasive colon cancer: how "NICE" is it? Gastrointest Endosc. 2013 Oct;78(4):633-6. doi: 10.1016/j.gie.2013.06.015. No abstract available.
PubMed 24054741Parsa N, Rex DK, Byrne MF. Colorectal polyp characterization with standard endoscopy: Will Artificial Intelligence succeed where human eyes failed? Best Pract Res Clin Gastroenterol. 2021 Jun-Aug;52-53:101736. doi: 10.1016/j.bpg.2021.101736. Epub 2021 Feb 22.
PubMed 34172255Mangas-Sanjuan C, Santana E, Cubiella J, Rodriguez-Camacho E, Seoane A, Alvarez-Gonzalez MA, Suarez A, Alvarez-Garcia V, Gonzalez N, Lue A, Cid-Gomez L, Ponce M, Bujanda L, Portillo I, Pellise M, Diez-Redondo P, Herraiz M, Ono A, Pizarro A, Zapater P, Jover R; QUALISCOPIA Study Investigators. Variation in Colonoscopy Performance Measures According to Procedure Indication. Clin Gastroenterol Hepatol. 2020 May;18(5):1216-1223.e2. doi: 10.1016/j.cgh.2019.08.035. Epub 2019 Aug 22.
PubMed 31446179
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.
- ClinicalTrials.gov ID
- NCT05513261
- Acronym / sponsor ID
- PolyDeep Advance 3.0
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal adenomas, Colorectal polyps, Serrated lesions, Polydeep, computer-aided System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 857 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, Ministry of Work and Welfare - Xunta de Galicia, Asociación Española de Gastroenterología, European Regional Development Fund
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 24 Aug 2022 (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.
This study is a clinical validation of PolyDeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. PolyDeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).
Detailed description
Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC, can reduce CRC incidence and mortality. Adenoma Detection Rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality.
Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE (NBI International Colorectal Endoscopic) Classification has proposed use high definition endoscopes that have Narrow Band Imaging (NBI). However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary.
Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, the CAD system aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion.
PolyDeep CAD is a functional prototype. This CAD system is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that PolyDeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated. The aim of PolyDeep advance 3 is to compare Adenoma Detection Rate differences in a randomized clinical trial. The investigators will compare the Adenoma Detection Rate between high definition colonoscopy and PolyDeep assisted high definition colonoscopy, both in CRC screening and surveillance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who fulfill criteria will be randomly allocated to high definition colonoscopy or Polydeep assisted high definition colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| Control arm: High definition colonoscopy | Other | Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection RateDiagnostic test: Standard colonoscopy |
| PolyDeep assisted high definition colonoscopy | Experimental | Diagnostic Test: PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection RateDiagnostic test: PolyDeep |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program.
- Surveillance after resection of colorectal adenomas
- Acceptance after reading the information sheet and signing informed consent.
Key exclusion criteria (6 listed)
- Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments).
- Incomplete colonoscopy without cecal intubation.
- Previous CRC
- Previous colonic resection.
- Hereditary CRC syndromes
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 |
|---|---|---|
| High definition colonoscopy (standard colonoscopy) in Adenoma Detection RateIn the intervention of this arm the investigators will apply the standard colonoscopy without computer-aided colonoscopy (polyDeep) | Diagnostic test | Control arm: High definition colonoscopy |
| PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection RateIn the intervention of this arm the investigators will apply polyDeep assisted high definition colonoscopy (CAD system). | Diagnostic test | PolyDeep assisted high definition colonoscopy |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: 1.5 years
Number of colonoscopies with adenomas/total number of colonoscopies. The investigators will evaluate if there are differences between both arms.
5 secondary outcomes
Polyp detection rate
Time frame: 1.5 years
Serrated lesion detection rate
Time frame: 1.5 years
Advanced lesion detection rate
Time frame: 1.5 years
Withdrawal time:
Time frame: 1.5 years
Characterization of the detected lesions.
Time frame: 1.5 years
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 24 Feb 2025.
- Background: PubMed 30245076Cubiella J, Marzo-Castillejo M, Mascort-Roca JJ, Amador-Romero FJ, Bellas-Beceiro B, Clofent-Vilaplana J, Carballal S, Ferrandiz-Santos J, Gimeno-Garcia AZ, Jover R, Mangas-Sanjuan C, Moreira L, Pellise M, Quintero E, Rodriguez-Camacho E, Vega-Villaamil P; Sociedad Espanola de Medicina de Familia y Comunitaria y Asociacion Espanola de Gastroenterologia. Clinical practice guideline. Diagnosis and prevention of colorectal cancer. 2018 Update. Gastroenterol Hepatol. 2018 Nov;41(9):585-596. doi: 10.1016/j.gastrohep.2018.07.012. Epub 2018 Sep 20. English, Spanish.
- Background: PubMed 24693890Corley 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.
- Background: PubMed 30738046Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
- Background: PubMed 32846754Liu A, Wang H, Lin Y, Fu L, Liu Y, Yan S, Chen H. Gastrointestinal endoscopy nurse assistance during colonoscopy and polyp detection: A PRISMA-compliant meta-analysis of randomized control trials. Medicine (Baltimore). 2020 Aug 21;99(34):e21278. doi: 10.1097/MD.0000000000021278.
- Background: PubMed 25597420ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
- Background: PubMed 30296432Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
- Background: PubMed 32119927Jin EH, Lee D, Bae JH, Kang HY, Kwak MS, Seo JY, Yang JI, Yang SY, Lim SH, Yim JY, Lim JH, Chung GE, Chung SJ, Choi JM, Han YM, Kang SJ, Lee J, Chan Kim H, Kim JS. Improved Accuracy in Optical Diagnosis of Colorectal Polyps Using Convolutional Neural Networks with Visual Explanations. Gastroenterology. 2020 Jun;158(8):2169-2179.e8. doi: 10.1053/j.gastro.2020.02.036. Epub 2020 Feb 29.
- Background: PubMed 32598963Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.
- Background: PubMed 26782820Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
- Background: PubMed 24054741Wani S, Rastogi A. Narrow-band imaging in the prediction of submucosal invasive colon cancer: how "NICE" is it? Gastrointest Endosc. 2013 Oct;78(4):633-6. doi: 10.1016/j.gie.2013.06.015. No abstract available.
- Background: PubMed 34172255Parsa N, Rex DK, Byrne MF. Colorectal polyp characterization with standard endoscopy: Will Artificial Intelligence succeed where human eyes failed? Best Pract Res Clin Gastroenterol. 2021 Jun-Aug;52-53:101736. doi: 10.1016/j.bpg.2021.101736. Epub 2021 Feb 22.
- Background: PubMed 31446179Mangas-Sanjuan C, Santana E, Cubiella J, Rodriguez-Camacho E, Seoane A, Alvarez-Gonzalez MA, Suarez A, Alvarez-Garcia V, Gonzalez N, Lue A, Cid-Gomez L, Ponce M, Bujanda L, Portillo I, Pellise M, Diez-Redondo P, Herraiz M, Ono A, Pizarro A, Zapater P, Jover R; QUALISCOPIA Study Investigators. Variation in Colonoscopy Performance Measures According to Procedure Indication. Clin Gastroenterol Hepatol. 2020 May;18(5):1216-1223.e2. doi: 10.1016/j.cgh.2019.08.035. Epub 2019 Aug 22.
- Polydeep websiteLink provided by the sponsor.
- 43th congress of digestive endoscopy spanish societyLink provided by the sponsor.
- Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There are not a plan to make Individual Participant Data (IPD)
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate and PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate in people with Colorectal Cancer, run by Fundacin Biomedica Galicia Sur at 3 sites in Spain.
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 6 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Adenoma Detection Rate (ADR) (time frame: 1.5 years). 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 NCT05513261, which also lists 12 linked publications.
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 24 Feb 2025.