Polyp Pretreatment Device for SSL Diagnosis

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.

Conditions

• Sessile Serrated Lesion

Interventions

DEVICE

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.

Sponsors & Collaborators

• Heilongjiang Provicial Hospital

  collaborator OTHER

• Ankang Central Hospital

  collaborator OTHER

• Huadong Hospital Affiliated with Fudan University, Shanghai

  collaborator UNKNOWN

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Ya'an People's Hospital

  collaborator UNKNOWN

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Chongqing General Hospital

  collaborator OTHER

• Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)

  collaborator UNKNOWN

• Shanxi Provincial People's Hospital

  collaborator OTHER_GOV

• Shanghai Sixth Hospital

  collaborator UNKNOWN

• People's Hospital of Leshan, Sichuan Province

  collaborator UNKNOWN

• The Third People's Hospital of Chengdu

  collaborator OTHER

• The Third People's Hospital of Jingdezhen

  collaborator UNKNOWN

• Ningbo Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator UNKNOWN

• Shandong Provincial Second People's Hospital

  collaborator UNKNOWN

• Changhai Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2028-05-01

Completion

2028-05-01