Screening ColonoscopyFuji AINCT04894708
Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy
A study testing colonoscopy in people with Screening Colonoscopy and Colonoscopic Control After Polypectomy, run by Universitätsklinikum Hamburg-Eppendorf at 10 sites in Germany.
Trial summary
Colonoscopy is currently the best method of detection of intestinal tumors and polyps, particularly because polyps can also be biopsied and removed. There is a clear correlation between the adenoma detection rate and prevented carcinomas, so adenoma detection rate is the main parameter for the outcome quality of… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopy, Colonoscopic Control After Polypectomy, Suspected Colon Polyps
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,572 participants
- Where
- 10 sitesGermany
- Study dates
- 28 Oct 2020to Sep 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons> 35 years of age who are capable of giving informed consent
- Planned diagnostic colonoscopy (clarification of symptoms, polyp follow-up)
- Screening colonoscopy for men >50 or women > 55 years of age
Who cannot join
- Colon bleeding
- Colon carcinoma
- Known polyps for removal
- Inflammatory bowel disease
- Colonic stenosis
- Other suspected colon disease for further clarification
Show all 10Show fewer
- Follow-up care after colon cancer surgery (partial colon resection)
- Anticoagulant drugs that make a biopsy or polypectomy impossible
- Poor general condition (ASA IV)
- Incomplete colonoscopy planned
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites, 8 recruiting
- Terminated
GastroZentrum Lippe
Bad Salzuflen, 32105
- Recruiting
Gastroenterologie am Bayerischen Platz
Berlin, 10825
Stefan Schubert, Dr., +49 30 814 59 ext. 190, gastroenterologen@berlin.de
Peter Amerding, Dr., +49 30 814 59 ext. 190, gastroenterologen@berlin.de
- Recruiting
University Hospital Bonn
Bonn, 53127
Dominik J Kaczmarek, PD Dr., +49 228-287 ext. 14338, Dominik.Kaczmarek@ukbonn.de
Dominik J Kaczmarek, PD Dr.
- Recruiting
St. Vinzenz-Hospital / Akademisches Lehrkrankenhaus der Universität zu Köln
Cologne, 50733
Philipp Zervoulakos, Dr., +49 221 7712 ext. 4660, philipp.zervoulakos@cellitinnen.de
Philipp Zervoulakos, Dr.
- Recruiting
University Hospital Eppendorf
Hamburg, 20246
Thomas Rösch, Prof. Dr, +49 40 7410 ext. 50098, t.roesch@uke.de
Guido Schachschal, Dr., +49 40 7410 ext. 50814, g.schachschal@uke.de
- Terminated
Gastroenterologiepraxis Dr. Moog
Kassel, Hesse, 34127
- Recruiting
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Albrecht Hoffmeister, Prof. Dr., +49 341 97 ext. 12240, albrecht.hoffmeister@medizin.uni-leipzig.de
Marcus Hollenbach, Dr., Marcus.Hollenbach@medizin.uni-leipzig.de
- Recruiting
University Hospital Magdeburg
Magdeburg, 39120
Jochen Weigt, PD Dr., jochen.weigt@med.ovgu.de
Jochen Weigt, PD Dr.
- Recruiting
Marienhospital Osnabrück
Osnabrück, 49074
Oliver Möschler, Dr., +49 541 326 ext. 4100, Oliver.Moeschler@niels-stensen-kliniken.de
Oliver Möschler, Dr.
- Recruiting
Asklepios Paulinen Klinik Wiesbaden
Wiesbaden, 65197
Andrea May, Prof. Dr., +49 611 847 ext. 2331, an.may@asklepios.com
Andrea May, Prof. Dr.
About this study
Official title: Prospective Randomized Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy
Colonoscopy is currently the best method of detection of intestinal tumors and polyps, particularly because polyps can also be biopsied and removed. There is a clear correlation between the adenoma detection rate and prevented carcinomas, so adenoma detection rate is the main parameter for the outcome quality of diagnostic colonoscopy. The efficiency of preventive colonoscopy needs optimisation by increase in adenoma detection rate, as it is known from many studies that approximately 15-30% of all adenomas can be overlooked. This mainly applies to smaller and flat adenomas. However, since even smaller polyps may be relevant for colorectal cancer development, the aim of colonoscopy should be to preferably be able to recognize all polyps and other changes.The latest and by far the most interesting development in this field is the use of artificial intelligence systems. They consist of a switched-on software with a small computer connected to the endoscope processor; the patient's introduced endoscope is completely unchanged.
The present study therefore compares the adenoma detection rate (ADR) of the latest generation of devices with high-resolution imaging from Fujifilm with and without the connection of artificial intelligence.
Read the detailed description
Methods of Computer Vision (CV) and Artificial Intelligence (AI) provide completely new opportunities, e.g. in the automatic polyp detection and differentiation of a lesion based on its endoscopic image. Computer vision using artificial intelligence methods means the application of "trained" so-called deep neural net (DNN) with a set of defined images (e.g. everyday scenes) and well-known solutions ( e.g. name of the pictured item; c.f. e.g. the "ImageNet Challenge"). The technical feasibility of using AI algorithms in endoscopy has already been proven in many cases. In the present study, it is an AI system from Fujifilm, which is already clinically usable. By using Fujifilm high-resolution imaging devices in colonoscopies, AI will be added randomly.
- Being tested
- colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
addition of polyp detection algorithm by Fujifilm
| Study group | Role | What they receive |
|---|---|---|
| AI colonoscopy | Other | colonoscopy with artificial intelligence added Receives: Procedure: colonoscopy |
| conventional colonoscopy | Sham comparator | conventional colonoscopy Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Difference in adenoma detection rate (all adenomas/all patients) between the two groups
Measured: during procedure to histological examination result, approximately 2 days
Secondary outcomes (7)
Patient rate difference
Differences in the patient rate with adenomas (adenoma detection rate, i.e. rate of patients with at least one adenoma)
Measured: during procedure to histological examination result, approximately 2 days
Adenoma subgroup differences
Differences subgroups of adenomas (flat, small, high-grade dysplasia)
Measured: histological examination result, approximately 2 days
rate of hyperplastic polyp detection in both groups
Differences in the detection of hyperplastic polyps
Measured: histological examination result, approximately 2 days
rate of polyp detection in preventive and diagnostic colonoscopy
Differences in preventive vs. diagnostic colonoscopy
Measured: during procedure to histological examination result, approximately 2 days
Switching number (BLI, LCI) in both groups
number of switches to visual support by colour filters
Measured: during procedure
incidence of reasons for switching to BLI/LCI
reasons for switching to visual support by colour filters
Measured: during procedure
quality of polyp detection rate by image evaluation
differential diagnosis of colon polyps in both groups with/without CADEYE)
Measured: until 2 months after recruitment stop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start28 Oct 2020
- Primary completionMay 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Screening ColonoscopyStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- FUJIFILM Deutschland, Branch office of FUJIFILM Europe GmbH
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Prof. dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894708
- Sponsor's protocol ID
- PV7284
- Acronym
- Fuji AI
- Status last verified
- Jun 2023
- First submitted
- 1 Dec 2020
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Imperiale TF, Glowinski EA, Lin-Cooper C, Larkin GN, Rogge JD, Ransohoff DF. Five-year risk of colorectal neoplasia after negative screening colonoscopy. N Engl J Med. 2008 Sep 18;359(12):1218-24. doi: 10.1056/NEJMoa0803597.
PubMed 18799558Winawer SJ, Zauber AG, Gerdes H, O'Brien MJ, Gottlieb LS, Sternberg SS, Bond JH, Waye JD, Schapiro M, Panish JF, et al. Risk of colorectal cancer in the families of patients with adenomatous polyps. National Polyp Study Workgroup. N Engl J Med. 1996 Jan 11;334(2):82-7. doi: 10.1056/NEJM199601113340204.
PubMed 8531963European Colorectal Cancer Screening Guidelines Working Group; von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinas JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Madai S, Marinho J, Maucec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Tornberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.
PubMed 23212726Millan MS, Gross P, Manilich E, Church JM. Adenoma detection rate: the real indicator of quality in colonoscopy. Dis Colon Rectum. 2008 Aug;51(8):1217-20. doi: 10.1007/s10350-008-9315-3. Epub 2008 May 24.
PubMed 18500502Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available.
PubMed 18464196Corley 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 24693890Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
PubMed 20463339Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.
PubMed 17167136Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
PubMed 22442161Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
PubMed 22056301Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
PubMed 19014944Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
PubMed 17681999Adler A, Roll S, Marowski B, Drossel R, Rehs HU, Willich SN, Riese J, Wiedenmann B, Rosch T; Berlin Private-Practice Gastroenterology Working Group. Appropriateness of colonoscopy in the era of colorectal cancer screening: a prospective, multicenter study in a private-practice setting (Berlin Colonoscopy Project 1, BECOP 1). Dis Colon Rectum. 2007 Oct;50(10):1628-38. doi: 10.1007/s10350-007-9029-y.
PubMed 17694415Schachschal G, Mayr M, Treszl A, Balzer K, Wegscheider K, Aschenbeck J, Aminalai A, Drossel R, Schroder A, Scheel M, Bothe CH, Bruhn JP, Burmeister W, Stange G, Bahr C, Kiesslich R, Rosch T. Endoscopic versus histological characterisation of polyps during screening colonoscopy. Gut. 2014 Mar;63(3):458-65. doi: 10.1136/gutjnl-2013-304562. Epub 2013 Jun 28.
PubMed 23812324Schachschal G, Sehner S, Choschzick M, Aust D, Brandl L, Vieth M, Wegscheider K, Baretton GB, Kirchner T, Sauter G, Rosch T. Impact of reassessment of colonic hyperplastic polyps by expert GI pathologists. Int J Colorectal Dis. 2016 Mar;31(3):675-83. doi: 10.1007/s00384-016-2523-8. Epub 2016 Feb 4.
PubMed 26847619
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on the Use of Artificial Intelligence (Fujifilm) for Polyp Detection in Colonoscopy
- ClinicalTrials.gov ID
- NCT04894708
- Acronym / sponsor ID
- Fuji AI / PV7284
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,572 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- FUJIFILM Deutschland, Branch office of FUJIFILM Europe GmbH
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 20 May 2021 (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.
Colonoscopy is currently the best method of detection of intestinal tumors and polyps, particularly because polyps can also be biopsied and removed. There is a clear correlation between the adenoma detection rate and prevented carcinomas, so adenoma detection rate is the main parameter for the outcome quality of diagnostic colonoscopy. The efficiency of preventive colonoscopy needs optimisation by increase in adenoma detection rate, as it is known from many studies that approximately 15-30% of all adenomas can be overlooked. This mainly applies to smaller and flat adenomas. However, since even smaller polyps may be relevant for colorectal cancer development, the aim of colonoscopy should be to preferably be able to recognize all polyps and other changes.The latest and by far the most interesting development in this field is the use of artificial intelligence systems. They consist of a switched-on software with a small computer connected to the endoscope processor; the patient's introduced endoscope is completely unchanged.
The present study therefore compares the adenoma detection rate (ADR) of the latest generation of devices with high-resolution imaging from Fujifilm with and without the connection of artificial intelligence.
Detailed description
Methods of Computer Vision (CV) and Artificial Intelligence (AI) provide completely new opportunities, e.g. in the automatic polyp detection and differentiation of a lesion based on its endoscopic image. Computer vision using artificial intelligence methods means the application of "trained" so-called deep neural net (DNN) with a set of defined images (e.g. everyday scenes) and well-known solutions ( e.g. name of the pictured item; c.f. e.g. the "ImageNet Challenge"). The technical feasibility of using AI algorithms in endoscopy has already been proven in many cases. In the present study, it is an AI system from Fujifilm, which is already clinically usable. By using Fujifilm high-resolution imaging devices in colonoscopies, AI will be added randomly.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI colonoscopy | Other | Procedure: colonoscopycolonoscopy with artificial intelligence added |
| conventional colonoscopy | Sham comparator | Procedure: colonoscopyconventional colonoscopy |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons> 35 years of age who are capable of giving informed consent
- Planned diagnostic colonoscopy (clarification of symptoms, polyp follow-up)
- Screening colonoscopy for men >50 or women > 55 years of age
Key exclusion criteria (10 listed)
- Colon bleeding
- Colon carcinoma
- Known polyps for removal
- Inflammatory bowel disease
- Colonic stenosis
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 |
|---|---|---|
| colonoscopyaddition of polyp detection algorithm by Fujifilm | Procedure or surgery | AI colonoscopy, conventional colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: during procedure to histological examination result, approximately 2 days
Difference in adenoma detection rate (all adenomas/all patients) between the two groups
7 secondary outcomes
Patient rate difference
Time frame: during procedure to histological examination result, approximately 2 days
Adenoma subgroup differences
Time frame: histological examination result, approximately 2 days
rate of hyperplastic polyp detection in both groups
Time frame: histological examination result, approximately 2 days
rate of polyp detection in preventive and diagnostic colonoscopy
Time frame: during procedure to histological examination result, approximately 2 days
Switching number (BLI, LCI) in both groups
Time frame: during procedure
incidence of reasons for switching to BLI/LCI
Time frame: during procedure
quality of polyp detection rate by image evaluation
Time frame: until 2 months after recruitment stop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Background: PubMed 18799558Imperiale TF, Glowinski EA, Lin-Cooper C, Larkin GN, Rogge JD, Ransohoff DF. Five-year risk of colorectal neoplasia after negative screening colonoscopy. N Engl J Med. 2008 Sep 18;359(12):1218-24. doi: 10.1056/NEJMoa0803597.
- Background: PubMed 8531963Winawer SJ, Zauber AG, Gerdes H, O'Brien MJ, Gottlieb LS, Sternberg SS, Bond JH, Waye JD, Schapiro M, Panish JF, et al. Risk of colorectal cancer in the families of patients with adenomatous polyps. National Polyp Study Workgroup. N Engl J Med. 1996 Jan 11;334(2):82-7. doi: 10.1056/NEJM199601113340204.
- Background: PubMed 23212726European Colorectal Cancer Screening Guidelines Working Group; von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinas JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Madai S, Marinho J, Maucec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Tornberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.
- Background: PubMed 18500502Millan MS, Gross P, Manilich E, Church JM. Adenoma detection rate: the real indicator of quality in colonoscopy. Dis Colon Rectum. 2008 Aug;51(8):1217-20. doi: 10.1007/s10350-008-9315-3. Epub 2008 May 24.
- Background: PubMed 18464196Bretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available.
- 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 20463339Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
- Background: PubMed 17167136Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006 Dec 14;355(24):2533-41. doi: 10.1056/NEJMoa055498.
- Background: PubMed 22442161Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
- Background: PubMed 22056301Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
- Background: PubMed 19014944Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
- Background: PubMed 17681999Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
- Individual participant dataSharing planned: No
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Colorectal Cancer (CRC) Screening
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.
Thomas Rösch, Prof. dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy in people with Screening Colonoscopy and Colonoscopic Control After Polypectomy, run by Universitätsklinikum Hamburg-Eppendorf at 10 sites in Germany.
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 10 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Rösch, Prof. Dr. (+49 40 7410 ext. 50098, t.roesch@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: during procedure to histological examination result, approximately 2 days). 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 NCT04894708, which also lists 20 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 28 Jun 2023.