Polyp Pretreatment Device for SSL Diagnosis

Starting soon · Not applicable

Conditions studied: Sessile Serrated Lesion

In brief

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.

Key facts

Study ID

NCT07601230

Run by

Changhai Hospital

People needed

1156

Starts

2026-06-15

Expected to finish

2028-05-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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