Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
NCT ID: NCT06937671
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
194 participants
INTERVENTIONAL
2025-05-01
2026-12-31
Brief Summary
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Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cold EMR
Control group patients that receive standard cold EMR treatment.
Cold EMR
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
Hybrid cold EMR
Intervention group patients. Patients will receive hybrid EMR treatment.
Hybrid EMR
Cold EMR with hot avulsion of any visible residual neoplasia within the resection bed, in addition to precise APC of the fibrotic bands that may harbor invisible neoplasia within the resection bed.
Interventions
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Cold EMR
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
Hybrid EMR
Cold EMR with hot avulsion of any visible residual neoplasia within the resection bed, in addition to precise APC of the fibrotic bands that may harbor invisible neoplasia within the resection bed.
Eligibility Criteria
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Inclusion Criteria
* Polyp size of at least 20 mm
* \- Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)
Exclusion Criteria
* Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
* Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare
* Inflammatory bowel disease
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Shah,Tilak
Medical Doctor
Principal Investigators
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Tilak Shah, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida (Weston Hospital)
Locations
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Cleveland Clinic Weston
Weston, Florida, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Madhusudhan Sanaka, M.D.
Role: primary
Other Identifiers
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25-126
Identifier Type: -
Identifier Source: org_study_id
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