Polyp Pretreatment Device for SSL Diagnosis

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.

NCT Number	NCT07601230
Lead Sponsor	Changhai Hospital Collaborators: Heilongjiang Provicial Hospital, Ankang Central Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Nanchang University, Ya'an People's Hospital, The Second Hospital of Hebei Medical University, Chongqing General Hospital, Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Shanxi Provincial People's Hospital, Shanghai Sixth Hospital, People's Hospital of Leshan, Sichuan Province, The Third People's Hospital of Chengdu, The Third People's Hospital of Jingdezhen, Ningbo Hospital of Integrated Traditional Chinese and Western Medicine, Shandong Provincial Hospital
Conditions	Sessile Serrated Lesion
Enrollment	1,156 participants
Start Date	2026-06-15
Primary Completion	2028-05-01 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-22