Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
1 other identifier
interventional
194
1 country
2
Brief Summary
The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps. Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
2 active sites
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
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 20, 2025
April 1, 2025
1.6 years
April 11, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of polyps
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
3-6 months after the procedure
Secondary Outcomes (4)
Adverse events
3-6 months after the procedure
Polyp recurrence rates
3-6 months after EMR procedure
Cost benefit analysis
3-6 months after the procedure
Subgroup polyp recurrence rate
3-6 months after the procedure
Study Arms (2)
Cold EMR
ACTIVE COMPARATORControl group patients that receive standard cold EMR treatment.
Hybrid cold EMR
EXPERIMENTALIntervention group patients. Patients will receive hybrid EMR treatment.
Interventions
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
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
You may qualify if:
- Adult patient (age 18 years or older)
- 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)
You may not qualify if:
- Polyps with previous failed resection attempts or polyp recurrence
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cleveland Clinic Weston
Weston, Florida, 33331, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tilak Shah, M.D.
Cleveland Clinic Florida (Weston Hospital)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 22, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 20, 2025
Record last verified: 2025-04