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

NCT06859125 | Completed DMC

• 1 other identifier: FF-2019-355
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colonoscopy; assisted device; adenoma detection rate; endo-wing

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR)

  The proportion of colonoscopies with at least one adenoma detected divided by the total number of colonoscopies performed in the particular intervention group

  From enrollment through study completion, an average of 8 months.

Secondary Outcomes (3)

• Distribution of adenomas

  From enrollment through study completion, an average of 8 months.

• Cecal intubation rate

  From enrollment through study completion, an average of 8 months.

• The extent of additional sedation used

  From enrollment through study completion, an average of 8 months.

Study Arms (2)

Standard Colonoscopy

ACTIVE COMPARATOR

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

Device: Standard Colonoscopy

Endo-wing

EXPERIMENTAL

Colonoscopies performed using Olympus Evis Exera III 90 series or Olympus Evis Lucera 260 series colonoscopes with Endo-wing™ (Shangxian Minimal Invasive Inc, China) attached at the distal tip of the scope

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

Interventions

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

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.

Endo-wing

Standard Colonoscopy DEVICE

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

Standard Colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who will be undergoing screening, diagnostic, surveillance and therapeutic colonoscopy at the HCTM Endoscopic Unit

You may not qualify if:

• Patients with colonic strictures,
• Patients with active colitis,
• Patients with known polyposis syndrome,
• Patients with known severe diverticulosis,
• Patients with known right hemicolectomy,
• Patients with colostomy/ileostomy and
• Patients with poor bowel preparation (Boston Bowel Preparation Scale (BBPS) score of 3 and below ).

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz (HCTM)

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Study Officials

• Nabil Mohammad Azmi Bin Dr, MBBS, Dr (Surgery)

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 5, 2025
• Study Start: September 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: March 10, 2025

Record last verified: 2025-02

Locations

MY (1)