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

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. 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 ( = 96) or Endo-Wing™-assisted colonoscopy ( = 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. 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 ( = 0.005, 0.035, and 0.035, respectively). Cecal intubation rates were similar in both groups ( > 0.999). The proportions of colonoscopy requiring increased sedation and standard sedation were similar in both groups ( = 0.613). No adverse effects of bleeding, perforation, and device dislodgement were reported in both groups. This study concludes that Endo-Wing™-assisted colonoscopy improves the ADR compared to standard colonoscopy.