Adenoma Detection Rate Using Endocuff Vision in China (SinoEVADR)

September 24, 2020 updated by: En-Da Yu, Changhai Hospital

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Sixth Affiliated Hospital, Sun Yat-sen University
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200032
        • Shanghai Zhongshan Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300121
        • Tianjin People's Hospital
      • Tianjin, Tianjin, China, 300100
        • Tianjin Nankai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients referred for screening, surveillance, or diagnostic colonoscopy
  • All patients must be able to give informed consent

Exclusion Criteria:

  • Patients with any absolute contraindications to colonoscopy
  • Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
  • Patients with known colon cancer or polyposis syndromes
  • Patients with known colonic strictures
  • Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
  • Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  • Patients lacking capacity to give informed consent
  • Pregnancy
  • Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
  • Patients who are attending for a therapeutic procedure or assessment of a known lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the procedure, up to 1 hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the procedure, up to 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Shanghai Zhongshan Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Tianjin Nankai Hospital
Tianjin People's Hospital

Investigators

  • Principal Investigator: En-Da YU, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SINOCOLO2019A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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