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Comparisons of Endo-Wing-assisted Colonoscopy Versus Standard Colonoscopy in Improving Adenoma Detection Rate in Symptomatic Patients Suspected of Colorectal Cancer

NCT06859125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-03-10

No results posted yet for this study

Summary

Colorectal cancer (CRC) is the most common cancer in Malaysia. Colonoscopy is the gold standard for bowel cancer screening and the diagnosis of bowel pathology. Adenoma detection rate (ADR) is an important intraprocedural quality indicator, where endoscopists with ADR below 20% had ratios for the development of cancer more than 10 times higher than endoscopists with ADR more than 20%. A low ADR can be due to inferior visualization, especially at locations proximal to colonic folds and flexures.

Endo-Wing™ (Shangxian Minimal Invasive Inc, China) is a medical-grade soft silicone rubber device that is attached to the end of a colonoscope. It has 6 soft wing-like projections that are bendable and pliable, which gives a superior visualization directly from its action of flattening the colonic folds and maintaining the central view of the colonoscope during withdrawal. This can improve the endoscopist's ADR. The purpose of this study is to compare the adenoma detection rate between standard colonoscopy and Endo-Wing™ assisted colonoscopy.

Conditions

  • Colorectal Adenoma

Interventions

DEVICE

Endo-Wing™ (Shangxian Minimal Invasive Inc, China)

Endo-Wing™ (Shangxian Minimal Invasive Inc, China) is a medical-grade soft silicone rubber device that is attached at the end of a colonoscope. It has 6 soft wing-like projections that are bendable and pliable, giving the endoscopist a superior visualization directly from its action of flattening the colonic folds and maintaining the central view of the colonoscope during withdrawal. This can improve the endoscopist's ADR.

DEVICE

Standard Colonoscopy

Colonoscopies performed using Olympus Evis Exera III 90 series or Olympus Evis Lucera 260 series colonoscopes without Endo-Wing attached at the tip of the colonoscope

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • Nabil Mohammad Azmi Bin Dr, MBBS, Dr (Surgery) · Universiti Kebangsaan Malaysia Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06859125 on ClinicalTrials.gov