Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial
EXCEED
Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial
1 other identifier
interventional
708
2 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2017
CompletedFirst Submitted
Initial submission to the registry
December 18, 2017
CompletedFirst Posted
Study publicly available on registry
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedFebruary 1, 2018
December 1, 2017
1.7 years
December 18, 2017
January 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Adenoma miss rate (%)
To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
18 months
Secondary Outcomes (12)
Adenoma detection rate (%)
18 months
Mean number of adenomas detected per colonoscopy procedure
18 months
Number of sessile serrated lesions per procedure
18 months
Total number of colon lesions found during first and second examination
18 months
Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)
18 months
- +7 more secondary outcomes
Study Arms (4)
2 x CC
ACTIVE COMPARATOR2 x conventional colonoscopy (CC), back-to-back design
CC followed by EC
ACTIVE COMPARATORConventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design
EC followed by CC
ACTIVE COMPARATOREndocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design
2 x EC
ACTIVE COMPARATOR2 x Endocuff Vision-assisted colonoscopy
Interventions
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
Eligibility Criteria
You may qualify if:
- Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Norginecollaborator
Study Sites (3)
"Attikon" University General Hospital,
Athens, Haidari, GR-12462, Greece
417 Army Veterans Hospital
Athens, 11521, Greece
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA, Netherlands
Related Publications (1)
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.
PMID: 37993062DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter D Siersema, MD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants will be blinded for the allocation. Physicians can not be blinded for the use of Endocuff, but during the first procedure they will be blinded for the second procedure method to limit observer related bias.
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2017
First Posted
February 1, 2018
Study Start
December 8, 2017
Primary Completion
September 1, 2019
Study Completion
November 1, 2019
Last Updated
February 1, 2018
Record last verified: 2017-12