Colon NeoplasmsNCT02340065
Endocuff-assisted vs. Standard Colonoscopy
A study testing standard colonoscopy and Endocuff-assisted colonoscopy in people with Colon Neoplasms, run by Attikon Hospital at 1 site in Greece.
Trial summary
The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Neoplasms
- What is being tested?
- standard colonoscopy and Endocuff-assisted colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2015to Apr 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults undergoing elective screening or surveillance colonoscopy
- symptomatic adults with indication for colonoscopy
Who cannot join
- age<18 and > 80 years
- poor overall health (ASA III, IV)
- recent abdominal surgery
- presence of abdominal wall hernias
- active colitis
- previous bowel resection
- inflammatory bowel disease
- polyposis syndromes
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital
Haidari, Attica, 12462
About this study
Official title: Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study
The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible changes regarding post-polypectomy surveillance programs following Endocuff utilization.
Read the detailed description
Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since Endocuff-assisted colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that Endocuff-assisted colonoscopy detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during Endocuff-assisted colonoscopy is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients.
A more extensive description regarding the investigators study is provided in the following fields.
- Conditions
- Colon Neoplasms
- Being tested
- standard colonoscopy, Endocuff-assisted colonoscopy
- Keywords
- colonoscopy, adenoma detection rate, Endocuff-assisted colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard colonoscopyProcedure or surgery
Also called conventional colonoscopy
examination of the colon with a conventional colonoscope
Endocuff-assisted colonoscopyProcedure or surgery
Also called Endocuff
examination of the colon with Endocuff-assisted colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| standard colonoscopy | Active comparator | total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy Receives: Procedure: Endocuff-assisted colonoscopy |
| Endocuff-assisted colonoscopy | Active comparator | total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy Receives: Procedure: standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number and rate of missed adenomas
in the entire colon
Measured: one week
Secondary outcomes (9)
number of adenomas and adenoma detection rate in the entire colon
with both Endocuff-assisted and standard colonoscopy
Measured: one week
number of adenomas and adenoma detection rate in the right colon
with both Endocuff-assisted and standard colonoscopy
Measured: one week
number of polyps and polyp detection rate in the entire colon
with both Endocuff-assisted and standard colonoscopy
Measured: one week
number of polyps and polyp detection rate in the right colon
with both Endocuff-assisted and standard colonoscopy
Measured: one week
colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)
colonoscopy completion rate, reason for incomplete colonoscopy
Measured: one week
intubation and withdrawal time
for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded)
Measured: one week
adverse events
adverse event rate
Measured: one week
endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) for Endocuff-assisted colonoscopy
Measured: one week
mean number of adenomas per procedure
with both Endocuff-assisted and standard colonoscopy
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATHANASIOS SIOULAS, Attikon Hospital
- Investigators
- KONSTANTINOS TRIANTAFYLLOU, PROF, Study chair, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, GreeceDIMITRIOS POLYMEROS, MD, Study director, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340065
- Sponsor's protocol ID
- ENDOCUFF-001
- Status last verified
- Jul 2016
- First submitted
- 13 Jan 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
PubMed 25470133Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.
PubMed 24921209Triantafyllou K, Polymeros D, Apostolopoulos P, Lopes Brandao C, Gkolfakis P, Repici A, Papanikolaou IS, Dinis-Ribeiro M, Alexandrakis G, Hassan C. Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study. Endoscopy. 2017 Nov;49(11):1051-1060. doi: 10.1055/s-0043-114412. Epub 2017 Aug 1.
PubMed 28763808
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study
- ClinicalTrials.gov ID
- NCT02340065
- Acronym / sponsor ID
- ENDOCUFF-001
- Conditions
- Colon Neoplasms
- Keywords
- colonoscopy, adenoma detection rate, Endocuff-assisted colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Jan 2015 (estimated)
- 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.
The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible changes regarding post-polypectomy surveillance programs following Endocuff utilization.
Detailed description
Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since Endocuff-assisted colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that Endocuff-assisted colonoscopy detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during Endocuff-assisted colonoscopy is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients.
A more extensive description regarding the investigators study is provided in the following fields.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard colonoscopy | Active comparator | Procedure: Endocuff-assisted colonoscopytotal polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy |
| Endocuff-assisted colonoscopy | Active comparator | Procedure: standard colonoscopytotal polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults undergoing elective screening or surveillance colonoscopy
- symptomatic adults with indication for colonoscopy
Key exclusion criteria (8 listed)
- age<18 and > 80 years
- poor overall health (ASA III, IV)
- recent abdominal surgery
- presence of abdominal wall hernias
- active colitis
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 colonoscopyAlso: conventional colonoscopyexamination of the colon with a conventional colonoscope | Procedure or surgery | Endocuff-assisted colonoscopy |
| Endocuff-assisted colonoscopyAlso: Endocuffexamination of the colon with Endocuff-assisted colonoscopy | Procedure or surgery | standard colonoscopy |
Primary outcome
number and rate of missed adenomas
Time frame: one week
in the entire colon
9 secondary outcomes
number of adenomas and adenoma detection rate in the entire colon
Time frame: one week
number of adenomas and adenoma detection rate in the right colon
Time frame: one week
number of polyps and polyp detection rate in the entire colon
Time frame: one week
number of polyps and polyp detection rate in the right colon
Time frame: one week
colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy)
Time frame: one week
intubation and withdrawal time
Time frame: one week
adverse events
Time frame: one week
endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
Time frame: one week
mean number of adenomas per procedure
Time frame: one week
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 14 Jul 2016.
- Background: PubMed 25470133Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
- Background: PubMed 24921209Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.
- Derived from this study: PubMed 28763808Triantafyllou K, Polymeros D, Apostolopoulos P, Lopes Brandao C, Gkolfakis P, Repici A, Papanikolaou IS, Dinis-Ribeiro M, Alexandrakis G, Hassan C. Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study. Endoscopy. 2017 Nov;49(11):1051-1060. doi: 10.1055/s-0043-114412. Epub 2017 Aug 1.
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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.
KONSTANTINOS TRIANTAFYLLOU, PROF study chair
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
DIMITRIOS POLYMEROS, MD study director
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
1 site 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 Endocuff-assisted colonoscopy in people with Colon Neoplasms, run by Attikon Hospital at 1 site in Greece.
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 2 inclusion and 8 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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
number and rate of missed adenomas (time frame: one week). 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 NCT02340065, which also lists 3 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 14 Jul 2016.