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.

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Key information

Conditions

Sessile Serrated Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Polyp Pretreatment Device

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.

Primary outcomes

SSL Diagnostic Rate (%)

Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Bai

CONTACT

[email protected]

86-021-31161335

Zhaoshen Li

CONTACT

[email protected]

86-021-31161365

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 22, 2026
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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