Colorectal NeoplasmsEXCEEDNCT03418948
Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial
A study testing CC followed by EC, EC followed by CC and 2x EC in people with Colorectal Neoplasms, run by Radboud University Medical Center at 3 sites in 2 countries.
Trial summary
The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- CC followed by EC, EC followed by CC and 2x EC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Dec 2017to 1 Nov 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy.
Who cannot join
- Prior surgical resection of any portion of the colon or a history of radiotherapy for any abdominal or pelvic disease.
- Personal history of colon cancer or polyposis syndrome.
- Familial adenomatous polyposis (FAP)
- Known colitis or suspicion of colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis).
- Lower gastro-intestinal bleeding requiring acute intervention.
- Suspicion of large bowel obstruction or toxic megacolon.
Show all 12Show fewer
- Prior incomplete colonoscopy (not including insufficient preparation).
- Patients referred for a therapeutic procedure or assessment of a known non-resected lesion.
- Not sufficiently corrected anticoagulation disorders
- Poor general condition (>3 American Society of Anesthesiologist)
- Overweight (>120 kg)
- Inability to provide informed consent.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Greece2 sites, 2 recruiting
- Recruiting
"Attikon" University General Hospital,
Athens, Haidari, GR-12462
Ioannis Papanikolaou, MD
- Recruiting
417 Army Veterans Hospital
Athens, 11521
george Alexandrakis
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA
Kelly E van Keulen, MD, +31611910792, kelly.vankeulen@radboudumc.nl
Peter D Siersema, MD, +31 (0)24 36 16999, peter.siersema@radboudumc.nl
About this study
Official title: Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial
The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.
Read the detailed description
Rationale: Population screening programs for colorectal cancers (CRC) are increasingly adapted as a public health initiative with the primary goal to prevent CRC and CRC related deaths. [2-4] The ultimate benefit of CRC screening relies on the detection and resection of (pre-)malignant colon lesions, and for this colonoscopy is the preferred modality. Recently, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon.[5-9] Most ICs are suspected to arise from missed colon lesions during colonoscopy. The retrograde approach of colonic inspections may contribute to colon lesions remaining undetected as it limits visualization of the proximal sides of haustral folds and flexures. Endocuff Vision® is a single-use, disposable medical device designed to improve the detection of colon lesions. The 'finger-like' projections of the device provide fold retraction allowing the visualization of otherwise hidden anatomical areas. Additionally, Endocuff Vision® may improve scope tip stability and prevent scope slippage.
Objectives:
- To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
- To compare adenoma detection rates (ADR) between EAC and CC
- To assess whether a proposed increased ADR and reduced AMR with EAC is indeed due to the fold-flattening device or merely a consequence of the second colonoscopy procedure performed.
- To assess the clinical relevance of the polyps missed during the first colonoscopy procedure.
Study design: This multicenter, randomized, same-day, back-to-back tandem colonoscopy trial will include four separate study groups: group A; CC followed by CC, Group B; CC followed by EAC, Group C; EAC followed by CC, and group D; EAC followed by EAC.
Study population: Patients between the ages of 40 and 75-years referred for screening (non-IFOBT based), diagnostic or surveillance colonoscopy.
Main study parameters/endpoints: The primary endpoint of the study will be AMR.
Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain) and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.
- Conditions
- Colorectal Neoplasms
- Being tested
- CC followed by EC, EC followed by CC, 2x EC, 2x CC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC followed by ECDevice
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
EC followed by CCDevice
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
2x ECDevice
EC = endocuff assisted colonoscopy
2x CCDevice
CC = conventional colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 2 x CC | Active comparator | 2 x conventional colonoscopy (CC), back-to-back design Receives: Device: 2x CC |
| CC followed by EC | Active comparator | Conventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design Receives: Device: CC followed by EC |
| EC followed by CC | Active comparator | Endocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design Receives: Device: EC followed by CC |
| 2 x EC | Active comparator | 2 x Endocuff Vision-assisted colonoscopy Receives: Device: 2x EC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma miss rate (%)
To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
Measured: 18 months
Secondary outcomes (12)
Adenoma detection rate (%)
To compare adenoma detection rates (ADR) between Endocuff Vision®-assisted and CC.
Measured: 18 months
Mean number of adenomas detected per colonoscopy procedure
Mean number of adenomas detected per colonoscopy procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.
Measured: 18 months
Number of sessile serrated lesions per procedure
Number of sessile serrated lesions per procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.
Measured: 18 months
Total number of colon lesions found during first and second examination
These polyps will be compared for size, colon distribution (coecum, ascending, transversum, descending, sigmoïd or rectum), morphologic (Paris classification) and histopathological characteristics (Vienna classification)
Measured: 18 months
Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)
To compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR throughout the trial (to assess a learning curve) between CC and EC
Measured: 18 months
Cecal intubation rate
To compare cecal intubation rates between both techniques.
Measured: 18 months
Bowel cleansing levels; using the Boston Bowel Preparation Scale (BBPS) ranging from 0-9)
To compare BBPS scores between both techniques. A BBPS score of 2 or more in each colon segment is considered adequate.
Measured: 18 months
Procedure times (minutes)
To compare procedure times; total procedure time, insertion time, mean polypectomy time, withdrawal time)
Measured: 18 months
Number of severe adverse events
To compare the number of severe adverse events between study groups. 1 month follow-up
Measured: 18 months
Sedation and analgesia use; type and amount
To compare the use of sedation and analgesia between study groups. Type of sedation and analgesia and amount will be compared
Measured: 18 months
Post-polypectomy surveillance guidelines; difference in surveillance intervals after the first and second procedure.
To compare post-colonoscopy surveillance intervals applying European and US surveillance guidelines.
Measured: 18 months
To compare patient reported outcomes e.g. pain
Visual Analog Scale 2 days and 1 month after the procedure
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start8 Dec 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Norgine
- Responsible party
- Sponsor
- Investigators
- Peter D Siersema, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418948
- Sponsor's protocol ID
- EXCEED study
- Acronym
- EXCEED
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Keulen KE, Papanikolaou IS, Mak TWC, Apostolopoulos P, Neumann H, Delconte G, Furnari M, Peters Y, Lau JYW, Polymeros D, Schrauwen RWN, Cavalcoli F, Koukoulioti E, Triantafyllou K, Anderson JC, Pohl H, Rex DK, Siersema PD. Comparison of adenoma miss rate and adenoma detection rate between conventional colonoscopy and colonoscopy with second-generation distal attachment cuff: a multicenter, randomized, back-to-back trial. Gastrointest Endosc. 2024 May;99(5):798-808.e3. doi: 10.1016/j.gie.2023.11.017. Epub 2023 Nov 20.
PubMed 37993062
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT03418948
- Acronym / sponsor ID
- EXCEED / EXCEED study
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 708 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Norgine
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 1 Feb 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.
The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.
Detailed description
Rationale: Population screening programs for colorectal cancers (CRC) are increasingly adapted as a public health initiative with the primary goal to prevent CRC and CRC related deaths. [2-4] The ultimate benefit of CRC screening relies on the detection and resection of (pre-)malignant colon lesions, and for this colonoscopy is the preferred modality. Recently, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon.[5-9] Most ICs are suspected to arise from missed colon lesions during colonoscopy. The retrograde approach of colonic inspections may contribute to colon lesions remaining undetected as it limits visualization of the proximal sides of haustral folds and flexures. Endocuff Vision® is a single-use, disposable medical device designed to improve the detection of colon lesions. The 'finger-like' projections of the device provide fold retraction allowing the visualization of otherwise hidden anatomical areas. Additionally, Endocuff Vision® may improve scope tip stability and prevent scope slippage.
Objectives:
- To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
- To compare adenoma detection rates (ADR) between EAC and CC
- To assess whether a proposed increased ADR and reduced AMR with EAC is indeed due to the fold-flattening device or merely a consequence of the second colonoscopy procedure performed.
- To assess the clinical relevance of the polyps missed during the first colonoscopy procedure.
Study design: This multicenter, randomized, same-day, back-to-back tandem colonoscopy trial will include four separate study groups: group A; CC followed by CC, Group B; CC followed by EAC, Group C; EAC followed by CC, and group D; EAC followed by EAC.
Study population: Patients between the ages of 40 and 75-years referred for screening (non-IFOBT based), diagnostic or surveillance colonoscopy.
Main study parameters/endpoints: The primary endpoint of the study will be AMR.
Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain) and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 x CC | Active comparator | Device: 2x CC2 x conventional colonoscopy (CC), back-to-back design |
| CC followed by EC | Active comparator | Device: CC followed by ECConventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design |
| EC followed by CC | Active comparator | Device: EC followed by CCEndocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design |
| 2 x EC | Active comparator | Device: 2x EC2 x Endocuff Vision-assisted colonoscopy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy.
Key exclusion criteria (12 listed)
- Prior surgical resection of any portion of the colon or a history of radiotherapy for any abdominal or pelvic disease.
- Personal history of colon cancer or polyposis syndrome.
- Familial adenomatous polyposis (FAP)
- Known colitis or suspicion of colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis).
- Lower gastro-intestinal bleeding requiring acute intervention.
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 |
|---|---|---|
| CC followed by ECCC = conventional colonoscopy EC = endocuff assisted colonoscopy | Device | CC followed by EC |
| EC followed by CCCC = conventional colonoscopy EC = endocuff assisted colonoscopy | Device | EC followed by CC |
| 2x ECEC = endocuff assisted colonoscopy | Device | 2 x EC |
| 2x CCCC = conventional colonoscopy | Device | 2 x CC |
Primary outcome
Adenoma miss rate (%)
Time frame: 18 months
To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
12 secondary outcomes
Adenoma detection rate (%)
Time frame: 18 months
Mean number of adenomas detected per colonoscopy procedure
Time frame: 18 months
Number of sessile serrated lesions per procedure
Time frame: 18 months
Total number of colon lesions found during first and second examination
Time frame: 18 months
Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)
Time frame: 18 months
Cecal intubation rate
Time frame: 18 months
Bowel cleansing levels; using the Boston Bowel Preparation Scale (BBPS) ranging from 0-9)
Time frame: 18 months
Procedure times (minutes)
Time frame: 18 months
Number of severe adverse events
Time frame: 18 months
Sedation and analgesia use; type and amount
Time frame: 18 months
Post-polypectomy surveillance guidelines; difference in surveillance intervals after the first and second procedure.
Time frame: 18 months
To compare patient reported outcomes e.g. pain
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 37993062van Keulen KE, Papanikolaou IS, Mak TWC, Apostolopoulos P, Neumann H, Delconte G, Furnari M, Peters Y, Lau JYW, Polymeros D, Schrauwen RWN, Cavalcoli F, Koukoulioti E, Triantafyllou K, Anderson JC, Pohl H, Rex DK, Siersema PD. Comparison of adenoma miss rate and adenoma detection rate between conventional colonoscopy and colonoscopy with second-generation distal attachment cuff: a multicenter, randomized, back-to-back trial. Gastrointest Endosc. 2024 May;99(5):798-808.e3. doi: 10.1016/j.gie.2023.11.017. Epub 2023 Nov 20.
- Individual participant dataSharing planned: Undecided
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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.
Peter D Siersema, MD principal investigator
Radboud University Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC followed by EC, EC followed by CC and 2x EC in people with Colorectal Neoplasms, run by Radboud University Medical Center at 3 sites in 2 countries.
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 12 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 1 Feb 2018. 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 Greece, Netherlands. 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 Kelly van Keulen, MD (+31611910792, kelly.vankeulen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma miss rate (%) (time frame: 18 months). 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 NCT03418948, which also lists 1 linked publication.
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 1 Feb 2018.