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Adenoma Detection Rate Using Endocuff Vision in China (SinoEVADR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Sixth Affiliated Hospital, Sun Yat-sen University
Shanghai Zhongshan Hospital
Tianjin People's Hospital
Tianjin Nankai Hospital
Information provided by (Responsible Party):
En-Da Yu, Changhai Hospital

Study Description
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Brief Summary:

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
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)
Primary Purpose: Diagnostic
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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Guangdong
Sixth affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655
China, Shanghai
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Changhai Hospital
Shanghai, Shanghai, China, 200433
China, Tianjin
Tianjin Nankai Hospital
Tianjin, Tianjin, China, 300100
Tianjin People's Hospital
Tianjin, Tianjin, China, 300121
Sponsors and Collaborators
Changhai Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Shanghai Zhongshan Hospital
Tianjin People's Hospital
Tianjin Nankai Hospital
Investigators
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Principal Investigator: En-Da YU Changhai Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: En-Da Yu, Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03839277    
Other Study ID Numbers: SINOCOLO2019A
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by En-Da Yu, Changhai Hospital:
adenoma detection rate
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical