Improvement in Adenoma Detection Rate with Distal Attachment Device Endo-Wing™-Assisted Colonoscopy: A Randomized Control Trial

Aim: Endo-Wing™ is a soft silicone device with six wing-like projections attached at the end of the colonoscope that provides superior visualization by flattening the colonic fold and helps to maintain a central view of the colonoscope during withdrawal. This study aims to compare the adenoma detection rate (ADR) between standard colonoscopy and Endo-Wing™-assisted colonoscopy. Methods: This is a single-center, single-blind, parallel-group, randomized, actively controlled, exploratory clinical trial conducted between July 2019 and April 2020. Participants aged 45 and above who were symptomatic of colorectal cancer (CRC) or with a history of adenoma and under active surveillance were included. Exclusion criteria included colonic strictures, tumors, active colitis, a previous history of polyposis syndrome, colostomy/ileostomy, or a BPPS score of 0. Participants were subsequently randomized to receive standard colonoscopy (n = 96) or Endo-Wing™-assisted colonoscopy (n = 96) at a 1:1 ratio using a central block randomization method with varying block sizes. The primary endpoint was the ADR, and the differences between the two groups were evaluated using univariable statistical methods. Results: The ADR, the number of adenomas, and the size of adenomas in the Endo-Wing™-assisted colonoscopy group were significantly higher compared to standard colonoscopy (p = 0.005, 0.035, and 0.035, respectively). Cecal intubation rates were similar in both groups (p > 0.999). The proportions of colonoscopy requiring increased sedation and standard sedation were similar in both groups (p = 0.613). No adverse effects of bleeding, perforation, and device dislodgement were reported in both groups. Conclusions: This study concludes that Endo-Wing™-assisted colonoscopy improves the ADR compared to standard colonoscopy.