An interventional study of Cold EMR and Hybrid EMR in Polyp of Colon and Endoscopic Mucosal Resection, sponsored by The Cleveland Clinic. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 194 is below the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group patients that receive standard cold EMR treatment.
Procedure: Cold EMR
Intervention group patients. Patients will receive hybrid EMR treatment.
Procedure: Hybrid EMR
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.
Recurrence of polyps
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Time frame: 3-6 months after the procedure
Adverse events
Composite of clinically important adverse events: (1) Perforation requiring hospitalization or surgery (2) Bleeding associated with at least 2-gram Hb drop or hospitalization or Intervention (3) Post-polypectomy syndrome requiring hospital admission
Time frame: 3-6 months after the procedure
Polyp recurrence rates
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Time frame: 3-6 months after EMR procedure
Cost benefit analysis
\- Cost-benefit analysis includes the costs of additional hospitalizations related to post-procedure complications and the cost of additional colonoscopies required to follow up treatment of recurrence. Costs will be calculated from a Medicare perspective.
Time frame: 3-6 months after the procedure
Subgroup polyp recurrence rate
\- Recurrence rates in the subgroup of patients with visible residual neoplasia after snare resection before utilizing forceps or cautery resection/ablation
Time frame: 3-6 months after the procedure
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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