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Not yet recruiting NCT07601230

Polyp Pretreatment Device for SSL Diagnosis

No phase Interventional Sessile Serrated Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polyp Pretreatment Device.
Who it may be relevant to
Registry conditions: Sessile Serrated Lesion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • SSL Diagnostic Rate (%) [Time frame: 7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 39351466
  • Kolb 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.00 PMID 26501882
  • Morales 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 24165815

Identifiers

NCT: NCT07601230 · CHSDR202601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗