Polyp Pretreatment Device for SSL Diagnosis
ConditionSessile Serrated Lesion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Polyp Pretreatment Device
DeviceThis 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.
Treatment groups
1,156 Participants
are divided into 2 treatment groupsGroup A: Polyp Pretreatment DeviceExperimental treatment 1 intervention
Group B: Standard ProcessingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
SSL Diagnostic Rate (%)
Time frame
7 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
Heilongjiang Provicial Hospital
Collaborator
Ankang Central Hospital
Collaborator
Huadong Hospital Affiliated with Fudan University, Shanghai
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Ya'an People's Hospital
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Chongqing General Hospital
Collaborator
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Collaborator
Shanxi Provincial People's Hospital
Collaborator
Shanghai Sixth Hospital
Collaborator
People's Hospital of Leshan, Sichuan Province
Collaborator
The Third People's Hospital of Chengdu
Collaborator
The Third People's Hospital of Jingdezhen
Collaborator
Ningbo Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Shandong Provincial Second People's Hospital
Collaborator
Source ClinicalTrials.gov
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