Colorectal CancerITAvisionNCT03612674
Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial
A study testing Standard colonoscopy and ARC Endocuff Vision in people with Colorectal Cancer and Colorectal Adenoma, run by Cancer Prevention and Research Institute, Italy at 12 sites in Italy.
Trial summary
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Colorectal Polyp
- What is being tested?
- Standard colonoscopy and ARC Endocuff Vision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 12 sitesItaly
- Study dates
- 4 Apr 2018to Aug 2019
- 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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with a positive FIT result in the frame of national screening program
Who cannot join
- Subjects younger than 50 years old
- Active Inflammatory Bowel Disease
- Known condition of cholic stenosis
- Acute diverticulitis
- Patient not able to sign a informed consent form
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 11 recruiting
- Not yet recruiting
Cazzavillan Hospital, Local Health Unit 8 Berica, Veneto Region
Arzignano, Vicenza, 36071
Maurizio Pantalena, MD, maurizio.pantalena@aulss8.veneto.it
- Not yet recruiting
San Martino Hospital, Local Health Unit 1 Dolomiti, Veneto Region
Belluno, BL, 32100
Bastianello Germanà, MD, bastianello.germana@aulss1.veneto.it
- Recruiting
Maggiore Hospital, Crema Territorial Health Care Company, Lombardia Region
Crema, Cremona, 26013
Elisabetta Buscarini, MD, elisabetta.buscarini@asst-crema.it
- Not yet recruiting
Santa Maria del Prato, Local Health Unit 1 Dolomiti, Veneto Region
Feltre, Belluno, 32032
Flavio Valiante, MD, flavio.valiante@aulss1.veneto.it
- Recruiting
Screening Unit, Oncological Network, Prevention and Research Institute
Florence, 50139
Grazia Grazzini, MD, g.grazzini@ispro.toscana.it
- Not yet recruiting
San Paolo Hospital Company - University Campus
Milan, 20142
Carmelo Luigiano, MD, carmelo.luigiano@ao-sanpaolo.it
- Not yet recruiting
Sant'Antonio Hospital, Local Health Unit 6 Euganea, Veneto Region
Padova, 35127
Erik Rosa Rizzotto, MD, erik.rosarizzotto@aulss6.veneto.it
- Active, not recruiting
Veneto Tumor Registry, Local Health Unit 4, Veneto Region
Padova, 35131
- Not yet recruiting
Santa Maria della Misericordia Hospital, Local Health Unit 5 Polesana, Veneto Region
Rovigo, 45100
Giuseppe Del Favero, MD, giuseppe.delfavero@aulss5.veneto.it
- Not yet recruiting
Ca' Foncello Hospital, Local Health Unit 2 Marca Trevigiana, Veneto Region
Treviso, 31100
Helena Salvat, MD, helenaheras.salvat@aulss2.veneto.it
- Not yet recruiting
Molinette Hospital, Città della Salute e della Scienza University Hospital Company
Turin, 10126
Arrigo Arrigoni, MD, aarrigoni@cittadellasalute.to.it
- Not yet recruiting
San Bonifacio Hospital, Local Health Unit 9 Scaligera, Veneto Region
Verona, 37047
Gianmarco Bulighin, MD, gianmarco.bulighin@aulss9.veneto.it
About this study
Official title: Adenoma Detection Rate With ARC Endocuff Vision Assisted Colonoscopy vs. Standard Colonoscopy in Colorectal Cancer Screening: a Multicenter Randomized Italian Study
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy.
Read more
Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.
Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.
Read the detailed description
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
It has been demonstrated that screening with fecal occult blood test (FOBT) significantly reduces mortality for CRC. Currently, population-based CRC screening programs using FOBT have been or are heading towards being implemented in many European countries. Fecal immunochemical test (FIT) has been adopted by most Italian Regions as the standard screening test, with total colonoscopy as diagnostic assessment in subjects resulted FIT positive. A significant impact of FIT-based screening on CRC mortality reduction has been observed in an Italian region after 10 years from screening implementation. Moreover, two studies carried out in a Northern-central area of Italy have shown a reduction in CRC incidence in subjects who attended FIT screening programs as compared to non-attendees.
Increasing colonoscopy quality is critical for the screening impact among population. Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy. ADR is defined as the proportion of colonoscopies during which at least one adenoma can be detected. A polish study showed that ADR was an independent predictor of the risk of interval colorectal cancer after screening colonoscopy. ADR has shown a direct correlation with: operator experience, cecal intubation, quality of bowel preparation, patient sedation, endoscope withdrawal time, presence of flat, depressed or subtle lesions, ability to visualize the proximal side of haustral folds, flexures (blind spots), rectal valves, and ileocecal valves.
On the other hand, colonoscopy is considered the gold standard for adenoma detection, but it has shown some limits. Data from colonoscopy studies showed that up to 25% of polyps were missed during colonoscopy and up to 8% of CRCs occurred within 3 years after a previous colonoscopy. Moreover, recent studies have shown that cancers post-colonoscopy are most likely due to missed lesions, rather than being new lesions.
For these reasons, industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.
Previous researches have studied the performance of colonoscope distal attachment devices. More specifically, a 2016 meta-analysis of more than 5,000 patients demonstrates that, compared to traditional colonoscopy, the use of an Endocuff device improves ADR without any adverse effect on procedural efficiency or increased risk of significant adverse events. Moreover, Facciorusso et al. in 2017 assessed only a modest improvement in ADR by using distal attachment devices, especially in low-performing endoscopists, while in 2018 Williet showed, with moderate-quality evidence, an improvement in ADR with EAC without major adverse events, especially for operators with low-to-moderate ADR.
Second-generation AEV is a soft plastic cap, to be applied on the top of the colonoscopy. The cap has a propylene-made cylindrical core, with a single row of flexible arms. During the colon intubation procedure the device is nearly invisible, while in the retraction phase the arms begin to work, opening up and pulling the colon walls, stretching convoluted tracts.
- Being tested
- Standard colonoscopy, ARC Endocuff Vision
- Keywords
- Mass screening, Adenoma detection rate, ARC Endocuff Vision, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard colonoscopyProcedure or surgery
Current standard of care colonoscopy.
ARC Endocuff VisionDevice
Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard colonoscopy (S) | Active comparator | A standard colonoscopy will be performed. Receives: Procedure: Standard colonoscopy |
| AEV assisted colonoscopy (E) | Experimental | Colonoscopy with ARC Endocuff Vision attached to the top of the scope will be performed. Receives: Device: ARC Endocuff Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Comparison of the number of adenomas (ADR) detected per subject between the Endocuff Vision colonoscopy and the standard colonoscopy.
Measured: Through study completion, an average of 1 year
Secondary outcomes (11)
Patient values
Comparison of ADR according to patient's age, sex, screening history (first or subsequent test) between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Measured: Day 1
Exam values
Comparison of cecum intubation, patient discomfort (with Visual Analogue Scale -VAS) between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
The Visual Analogue Scale goes from 1 to 10, where 1 is the absence pain and 10 is severe pain.
Number 1 represents the best outcome measure, while 10 is the worst result for this outcome measure.
Measured: Day 1
Number of lesions
Comparison of polyps number between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Measured: Day 1
Size
Comparison of polyps size between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Measured: Day 1
Anatomical site
Comparison of polyps anatomical site between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Measured: Day 1
Histological diagnoses
Comparison of polyps histological diagnoses between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Measured: Through study completion, an average of 1 year
Colonoscopist' age
Analysis of the involved colonoscopists' age.
Measured: Through study completion, an average of 1 year
Colonoscopist' years of experience
Analysis of the involved colonoscopists' years of experience.
Measured: Through study completion, an average of 1 year
Colonoscopist' specialization
Analysis of the involved colonoscopists' specialization.
Measured: Through study completion, an average of 1 year
Colonoscopist' number of exams in the previous year
Analysis of the involved colonoscopists' number of exams in the previous year.
Measured: Through study completion, an average of 1 year
Colonoscopists' ADR in the previous year
Analysis of the involved colonoscopists' ADR in the previous year.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start4 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in two arms: a control-arm and an experimental-arm. Then arms data will be compared.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Prevention and Research Institute, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Veneto Tumor Registry, Azienda Zero, Padua, Italy
- Responsible party
- Sponsor
- Investigators
- Gianni Amunni, MD, Study director, Oncological Network, Prevention and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612674
- Sponsor's protocol ID
- F17G18000000007
- Acronym
- ITAvision
- Status last verified
- Jun 2018
- First submitted
- 2 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zorzi M, Senore C, Da Re F, Barca A, Bonelli LA, Cannizzaro R, Fasoli R, Di Furia L, Di Giulio E, Mantellini P, Naldoni C, Sassatelli R, Rex D, Hassan C, Zappa M; Equipe Working Group. Quality of colonoscopy in an organised colorectal cancer screening programme with immunochemical faecal occult blood test: the EQuIPE study (Evaluating Quality Indicators of the Performance of Endoscopy). Gut. 2015 Sep;64(9):1389-96. doi: 10.1136/gutjnl-2014-307954. Epub 2014 Sep 16.
PubMed 25227521Giorgi Rossi P, Vicentini M, Sacchettini C, Di Felice E, Caroli S, Ferrari F, Mangone L, Pezzarossi A, Roncaglia F, Campari C, Sassatelli R, Sacchero R, Sereni G, Paterlini L, Zappa M. Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. Am J Gastroenterol. 2015 Sep;110(9):1359-66. doi: 10.1038/ajg.2015.240. Epub 2015 Aug 25.
PubMed 26303133Corley 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 20463339Munroe CA, Lee P, Copland A, Wu KK, Kaltenbach T, Soetikno RM, Friedland S. A tandem colonoscopy study of adenoma miss rates during endoscopic training: a venture into uncharted territory. Gastrointest Endosc. 2012 Mar;75(3):561-7. doi: 10.1016/j.gie.2011.11.037.
PubMed 22341103Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.
PubMed 22104756Rees CJ, Rajasekhar PT, Rutter MD, Dekker E. Quality in colonoscopy: European perspectives and practice. Expert Rev Gastroenterol Hepatol. 2014 Jan;8(1):29-47. doi: 10.1586/17474124.2014.858599. Epub 2013 Dec 2.
PubMed 24410471van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
PubMed 16454841Leufkens AM, van Oijen MG, Vleggaar FP, Siersema PD. Factors influencing the miss rate of polyps in a back-to-back colonoscopy study. Endoscopy. 2012 May;44(5):470-5. doi: 10.1055/s-0031-1291666. Epub 2012 Mar 22.
PubMed 22441756Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
PubMed 8978338Pullens HJ, Siersema PD. Quality indicators for colonoscopy: Current insights and caveats. World J Gastrointest Endosc. 2014 Dec 16;6(12):571-83. doi: 10.4253/wjge.v6.i12.571.
PubMed 25512766le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
PubMed 23744612Pohl H, Robertson DJ. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol. 2010 Oct;8(10):858-64. doi: 10.1016/j.cgh.2010.06.028. Epub 2010 Jul 22.
PubMed 20655393Chin M, Karnes W, Jamal MM, Lee JG, Lee R, Samarasena J, Bechtold ML, Nguyen DL. Use of the Endocuff during routine colonoscopy examination improves adenoma detection: A meta-analysis. World J Gastroenterol. 2016 Nov 21;22(43):9642-9649. doi: 10.3748/wjg.v22.i43.9642.
PubMed 27920485Facciorusso A, Del Prete V, Buccino RV, Della Valle N, Nacchiero MC, Monica F, Cannizzaro R, Muscatiello N. Comparative Efficacy of Colonoscope Distal Attachment Devices in Increasing Rates of Adenoma Detection: A Network Meta-analysis. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1209-1219.e9. doi: 10.1016/j.cgh.2017.11.007. Epub 2017 Nov 11.
PubMed 29133257
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoma Detection Rate With ARC Endocuff Vision Assisted Colonoscopy vs. Standard Colonoscopy in Colorectal Cancer Screening: a Multicenter Randomized Italian Study
- ClinicalTrials.gov ID
- NCT03612674
- Acronym / sponsor ID
- ITAvision / F17G18000000007
- Keywords
- Mass screening, Adenoma detection rate, ARC Endocuff Vision, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Cancer Prevention and Research Institute, ItalyUniversity, hospital or other
- Collaborators
- Veneto Tumor Registry, Azienda Zero, Padua, Italy
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 2 Aug 2018 (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.
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy.
Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.
Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.
Detailed description
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
It has been demonstrated that screening with fecal occult blood test (FOBT) significantly reduces mortality for CRC. Currently, population-based CRC screening programs using FOBT have been or are heading towards being implemented in many European countries. Fecal immunochemical test (FIT) has been adopted by most Italian Regions as the standard screening test, with total colonoscopy as diagnostic assessment in subjects resulted FIT positive. A significant impact of FIT-based screening on CRC mortality reduction has been observed in an Italian region after 10 years from screening implementation. Moreover, two studies carried out in a Northern-central area of Italy have shown a reduction in CRC incidence in subjects who attended FIT screening programs as compared to non-attendees.
Increasing colonoscopy quality is critical for the screening impact among population. Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy. ADR is defined as the proportion of colonoscopies during which at least one adenoma can be detected. A polish study showed that ADR was an independent predictor of the risk of interval colorectal cancer after screening colonoscopy. ADR has shown a direct correlation with: operator experience, cecal intubation, quality of bowel preparation, patient sedation, endoscope withdrawal time, presence of flat, depressed or subtle lesions, ability to visualize the proximal side of haustral folds, flexures (blind spots), rectal valves, and ileocecal valves.
On the other hand, colonoscopy is considered the gold standard for adenoma detection, but it has shown some limits. Data from colonoscopy studies showed that up to 25% of polyps were missed during colonoscopy and up to 8% of CRCs occurred within 3 years after a previous colonoscopy. Moreover, recent studies have shown that cancers post-colonoscopy are most likely due to missed lesions, rather than being new lesions.
For these reasons, industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.
Previous researches have studied the performance of colonoscope distal attachment devices. More specifically, a 2016 meta-analysis of more than 5,000 patients demonstrates that, compared to traditional colonoscopy, the use of an Endocuff device improves ADR without any adverse effect on procedural efficiency or increased risk of significant adverse events. Moreover, Facciorusso et al. in 2017 assessed only a modest improvement in ADR by using distal attachment devices, especially in low-performing endoscopists, while in 2018 Williet showed, with moderate-quality evidence, an improvement in ADR with EAC without major adverse events, especially for operators with low-to-moderate ADR.
Second-generation AEV is a soft plastic cap, to be applied on the top of the colonoscopy. The cap has a propylene-made cylindrical core, with a single row of flexible arms. During the colon intubation procedure the device is nearly invisible, while in the retraction phase the arms begin to work, opening up and pulling the colon walls, stretching convoluted tracts.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be randomized in two arms: a control-arm and an experimental-arm. Then arms data will be compared.
| Arm | Type | Receives |
|---|---|---|
| Standard colonoscopy (S) | Active comparator | Procedure: Standard colonoscopyA standard colonoscopy will be performed. |
| AEV assisted colonoscopy (E) | Experimental | Device: ARC Endocuff VisionColonoscopy with ARC Endocuff Vision attached to the top of the scope will be performed. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject with a positive FIT result in the frame of national screening program
Key exclusion criteria (5 listed)
- Subjects younger than 50 years old
- Active Inflammatory Bowel Disease
- Known condition of cholic stenosis
- Acute diverticulitis
- Patient not able to sign a informed consent form
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 |
|---|---|---|
| Standard colonoscopyCurrent standard of care colonoscopy. | Procedure or surgery | Standard colonoscopy (S) |
| ARC Endocuff VisionSubjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure. | Device | AEV assisted colonoscopy (E) |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: Through study completion, an average of 1 year
Comparison of the number of adenomas (ADR) detected per subject between the Endocuff Vision colonoscopy and the standard colonoscopy.
11 secondary outcomes
Patient values
Time frame: Day 1
Exam values
Time frame: Day 1
Number of lesions
Time frame: Day 1
Size
Time frame: Day 1
Anatomical site
Time frame: Day 1
Histological diagnoses
Time frame: Through study completion, an average of 1 year
Colonoscopist' age
Time frame: Through study completion, an average of 1 year
Colonoscopist' years of experience
Time frame: Through study completion, an average of 1 year
Colonoscopist' specialization
Time frame: Through study completion, an average of 1 year
Colonoscopist' number of exams in the previous year
Time frame: Through study completion, an average of 1 year
Colonoscopists' ADR in the previous year
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Background: PubMed 25227521Zorzi M, Senore C, Da Re F, Barca A, Bonelli LA, Cannizzaro R, Fasoli R, Di Furia L, Di Giulio E, Mantellini P, Naldoni C, Sassatelli R, Rex D, Hassan C, Zappa M; Equipe Working Group. Quality of colonoscopy in an organised colorectal cancer screening programme with immunochemical faecal occult blood test: the EQuIPE study (Evaluating Quality Indicators of the Performance of Endoscopy). Gut. 2015 Sep;64(9):1389-96. doi: 10.1136/gutjnl-2014-307954. Epub 2014 Sep 16.
- Background: PubMed 26303133Giorgi Rossi P, Vicentini M, Sacchettini C, Di Felice E, Caroli S, Ferrari F, Mangone L, Pezzarossi A, Roncaglia F, Campari C, Sassatelli R, Sacchero R, Sereni G, Paterlini L, Zappa M. Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. Am J Gastroenterol. 2015 Sep;110(9):1359-66. doi: 10.1038/ajg.2015.240. Epub 2015 Aug 25.
- 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 22341103Munroe CA, Lee P, Copland A, Wu KK, Kaltenbach T, Soetikno RM, Friedland S. A tandem colonoscopy study of adenoma miss rates during endoscopic training: a venture into uncharted territory. Gastrointest Endosc. 2012 Mar;75(3):561-7. doi: 10.1016/j.gie.2011.11.037.
- Background: PubMed 22104756Faiss S. The missed colorectal cancer problem. Dig Dis. 2011;29 Suppl 1:60-3. doi: 10.1159/000331119. Epub 2011 Nov 15.
- Background: PubMed 24410471Rees CJ, Rajasekhar PT, Rutter MD, Dekker E. Quality in colonoscopy: European perspectives and practice. Expert Rev Gastroenterol Hepatol. 2014 Jan;8(1):29-47. doi: 10.1586/17474124.2014.858599. Epub 2013 Dec 2.
- Background: PubMed 16454841van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
- Background: PubMed 22441756Leufkens AM, van Oijen MG, Vleggaar FP, Siersema PD. Factors influencing the miss rate of polyps in a back-to-back colonoscopy study. Endoscopy. 2012 May;44(5):470-5. doi: 10.1055/s-0031-1291666. Epub 2012 Mar 22.
- Background: PubMed 8978338Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
- Background: PubMed 25512766Pullens HJ, Siersema PD. Quality indicators for colonoscopy: Current insights and caveats. World J Gastrointest Endosc. 2014 Dec 16;6(12):571-83. doi: 10.4253/wjge.v6.i12.571.
- Background: PubMed 23744612le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
- 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.
Gianni Amunni, MD study director
Oncological Network, Prevention and Research Institute
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard colonoscopy and ARC Endocuff Vision in people with Colorectal Cancer and Colorectal Adenoma, run by Cancer Prevention and Research Institute, Italy at 12 sites in Italy.
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 1 inclusion and 5 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 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grazia Grazzini, MD (003905532697972, g.grazzini@ispro.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) (time frame: Through study completion, an average of 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 NCT03612674, which also lists 17 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 2 Aug 2018.