Polyp Pretreatment Device for SSL Diagnosis
Efficacy of a Polyp Pretreatment Device in Improving Diagnosis of Sessile Serrated Lesions in Colorectal Polyps
1 other identifier
interventional
1,156
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
Study Completion
Last participant's last visit for all outcomes
May 1, 2028
May 22, 2026
May 1, 2026
1.9 years
May 17, 2026
May 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
SSL Diagnostic Rate (%)
7 days
Study Arms (2)
Polyp Pretreatment Device
EXPERIMENTALStandard Processing
NO INTERVENTIONInterventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- Heilongjiang Provicial Hospitalcollaborator
- Ankang Central Hospitalcollaborator
- Huadong Hospital Affiliated with Fudan University, Shanghaicollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Ya'an People's Hospitalcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- Chongqing General Hospitalcollaborator
- Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)collaborator
- Shanxi Provincial People's Hospitalcollaborator
- Shanghai Sixth Hospitalcollaborator
- People's Hospital of Leshan, Sichuan Provincecollaborator
- The Third People's Hospital of Chengducollaborator
- The Third People's Hospital of Jingdezhencollaborator
- Ningbo Hospital of Integrated Traditional Chinese and Western Medicinecollaborator
- Shandong Provincial Second People's Hospitalcollaborator
Related Publications (3)
Tran TH, Nguyen VH, Vo DT. How to "pick up" colorectal serrated lesions and polyps in daily histopathology practice: From terminologies to diagnostic pitfalls. World J Clin Oncol. 2024 Sep 24;15(9):1157-1167. doi: 10.5306/wjco.v15.i9.1157.
PMID: 39351466BACKGROUNDKolb JM, Morales SJ, Rouse NA, Desai J, Friedman K, Makris L, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Rouse RV, Aisenberg J. Does Better Specimen Orientation and a Simplified Grading System Promote More Reliable Histologic Interpretation of Serrated Colon Polyps in the Community Practice Setting? Results of a Nationwide Study. J Clin Gastroenterol. 2016 Mar;50(3):233-8. doi: 10.1097/MCG.0000000000000413.
PMID: 26501882BACKGROUNDMorales SJ, Bodian CA, Kornacki S, Rouse RV, Petras R, Rouse NA, Cohen LB, Bamji ND, Miller KM, Soetikno RM, Kaltenbach T, Aisenberg J. A simple tissue-handling technique performed in the endoscopy suite improves histologic section quality and diagnostic accuracy for serrated polyps. Endoscopy. 2013 Nov;45(11):897-905. doi: 10.1055/s-0033-1344435. Epub 2013 Oct 28.
PMID: 24165815BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,Director, Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05