Adenoma Detection Rate Using Endocuff Vision in China (SinoEVADR)
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|ClinicalTrials.gov Identifier: NCT03839277|
Recruitment Status : Suspended (One investigator is out-of-service due to carrying out another task.)
First Posted : February 15, 2019
Last Update Posted : September 28, 2020
The primary aim of this study is
- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).
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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Colonic Polyp Adenoma||Device: Endocuff Vision||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).|
|Masking:||None (Open Label)|
|Official Title:||Adenoma Detection Rate Using Endocuff Vision in China|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Active Comparator: Endocuff Vision-assisted Colonoscopy
Participants in this arm undergo Endocuff Vision-assisted colonoscopy
Device: Endocuff Vision
Endocuff Vision is attached to the tip of colonoscope before intubation.
No Intervention: Standard Colonoscopy
Participants in this arm undergo standard colonoscopy
- Adenoma detection rate, ADR [ Time Frame: At the end of the procedure, up to 1 hour. ]ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
- Polyp detection rate, PDR [ Time Frame: At the end of the procedure, up to 1 hour. ]PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839277
|Sixth affiliated Hospital, Sun Yat-Sen University|
|Guangzhou, Guangdong, China, 510655|
|Shanghai Zhongshan Hospital|
|Shanghai, Shanghai, China, 200032|
|Shanghai, Shanghai, China, 200433|
|Tianjin Nankai Hospital|
|Tianjin, Tianjin, China, 300100|
|Tianjin People's Hospital|
|Tianjin, Tianjin, China, 300121|
|Principal Investigator:||En-Da YU||Changhai Hospital|