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Polyp Pretreatment Device for SSL Diagnosis
Sponsor: Changhai Hospital
Summary
Colorectal cancer (CRC) is the third most common malignancy globally. Sessile serrated lesions (SSLs) account for 15-30% of CRC via the serrated pathway. Accurate SSL diagnosis relies on basal crypt features, which are often obscured by specimen curling during standard formalin fixation, leading to underdiagnosis. A novel polyp pretreatment device mechanically maintains mucosal flatness, ensuring vertical sectioning relative to the muscularis mucosae. This randomized, double-blind, parallel-controlled trial evaluates whether the device improves SSL diagnostic rate and section orientation in sessile colorectal polyps.
Official title: Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1156
Start Date
2026-06-15
Completion Date
2028-05-01
Last Updated
2026-05-22
Healthy Volunteers
Yes
Conditions
Interventions
Polyp Pretreatment Device
This novel polyp pretreatment device is a single-use, non-invasive laboratory tool designed to standardize the orientation and fixation of resected colorectal polyp specimens. The device consists of a flat, rigid base with a transparent, non-adherent cover, and is engineered to maintain the mucosal surface of the polyp specimen flat and fully extended.