Polyp Pretreatment Device for SSL Diagnosis

May 17, 2026 updated by: Zhaoshen Li, Changhai Hospital

Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients undergoing colonoscopic polypectomy (≤3 lesions if multiple).
  2. Sessile/flat polyps (Paris 0-Is,0-IIa, 0-IIb, 0-IIc) resected by snare or EMR with intact specimens.
  3. Signed informed consent.

Exclusion Criteria:

  1. Refusal or lack of informed consent.
  2. Polyp size ≥25 mm or fragmented resection.
  3. Severe specimen damage/cautery artifact or time from resection to fixation >30 min.
  4. Suspected/confirmed CRC, IBD, or polyposis syndromes.
  5. Anticoagulants (aspirin/warfarin) within 7 days or coagulation disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyp Pretreatment Device
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.
No Intervention: Standard Processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SSL Diagnostic Rate (%)
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

The First Affiliated Hospital of Nanchang University
The Second Hospital of Hebei Medical University
Ankang Central Hospital
Shanxi Provincial People's Hospital
Chongqing General Hospital
The Third People's Hospital of Chengdu
Heilongjiang Provicial Hospital
People's Hospital of Leshan, Sichuan Province
Huadong Hospital Affiliated with Fudan University, Shanghai
The Third People's Hospital of Jingdezhen
Ya'an People's Hospital
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Shanghai Sixth Hospital
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
Shandong Provincial Second People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CHSDR202601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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