Status:
UNKNOWN
Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Norgine
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
40-75 years
Phase:
NA
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.
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 ul...
Eligibility Criteria
Inclusion
- Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy.
Exclusion
- 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.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2019
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT03418948
Start Date
December 8 2017
End Date
November 1 2019
Last Update
February 1 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
"Attikon" University General Hospital,
Athens, Haidari, Greece, GR-12462
2
417 Army Veterans Hospital
Athens, Greece, 11521
3
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA