An interventional study of Endocuff Vision in Colorectal Neoplasms, Colonic Polyp and Adenoma, sponsored by Changhai Hospital. Suspended at 5 sites in China. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-28.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Diagnostic
The primary aim of this study is
Other aims include to explore the data below when Endocuff Vision is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm undergo Endocuff Vision-assisted colonoscopy
Device: Endocuff Vision
Participants in this arm undergo standard colonoscopy
Endocuff Vision is attached to the tip of colonoscope before intubation.
Adenoma detection rate, ADR
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Time frame: At the end of the procedure, up to 1 hour.
Polyp detection rate, PDR
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
Time frame: At the end of the procedure, up to 1 hour.
Plan to share: No
This study is suspended, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Changhai Hospital