Cold vs Hybrid Cold EMR for Colon Polyps

Recruiting at 1 trial location

Overseen By Akram Ahmad, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Failed resection, Malignancy, Large nodules, IBD

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether combining hot and cold EMR (endoscopic mucosal resection) techniques can reduce the chance of polyp regrowth without adding extra risks during the removal of large colon polyps. Participants will receive either the standard cold EMR treatment or the new hybrid EMR treatment (a combination of hot and cold EMR) and then return for a follow-up in 3-6 months to check for any polyp recurrence. The trial seeks adults with flat or slightly raised polyps that are at least 20 mm in size. Those with a history of failed polyp removal or certain other conditions are not eligible. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cold endoscopic mucosal resection (EMR) for removing colon polyps is generally safe, with a low risk of complications such as bleeding. Cold EMR is considered safer than the hot EMR method, reducing the likelihood of problems during or after the procedure.

Studies have found hybrid cold EMR to be similarly safe, with a low rate of serious side effects. This method is under investigation to determine if it can reduce the recurrence of polyps while maintaining safety.

In summary, both cold EMR and hybrid cold EMR are well-tolerated, with few reported complications, suggesting these treatments are relatively safe options for removing polyps. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for colon polyps because they offer innovative ways to remove polyps with potentially fewer complications. Cold EMR (Endoscopic Mucosal Resection) is a widely used technique that removes polyps without using heat, minimizing damage to surrounding tissues. The hybrid cold EMR takes this a step further by combining the cold technique with an injection to lift the polyp, which might make removal easier and reduce the risk of bleeding. By exploring these methods, researchers hope to enhance the safety and effectiveness of polyp removal, leading to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for colon polyps?

This trial will compare Cold EMR with Hybrid Cold EMR for removing colon polyps. Research has shown that cold endoscopic mucosal resection (EMR) is safer and more cost-effective for removing large colon polyps than traditional hot techniques. Studies have found that standard EMR methods can lead to polyps returning in 10% to 30% of cases. In this trial, some participants will receive standard Cold EMR, while others will receive Hybrid Cold EMR. New hybrid procedures, which combine different methods, have proven effective for treating complex colorectal growths that are difficult to remove with standard EMR alone. These hybrid methods have been shown to lower the chance of polyps returning, making them a promising option for more thorough removal. Overall, combining techniques in hybrid EMR may lead to better results in reducing polyp recurrence while maintaining safety. ^{2 3 6 7 8}

Who Is on the Research Team?

Tilak Shah, M.D.

Principal Investigator

Cleveland Clinic Florida (Weston Hospital)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with large colon polyps (at least 20mm) that are flat or slightly raised. It's not for those who've had failed polyp removals, suspected deep cancer invasion, very large nodules unsuitable for cold snare use, or inflammatory bowel disease.

Inclusion Criteria

Polyp size of at least 20 mm

My polyp is flat or slightly raised.

Exclusion Criteria

My tests show advanced cancer or confirmed invasive adenocarcinoma.

My polyps are too large for cold snare removal.

I have inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EMR using either cold or hybrid cold EMR techniques

Follow-up

Participants return for a follow-up endoscopy to check for polyp recurrence

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cold EMR
• Hybrid EMR

Trial Overview The study compares two ways to remove colon polyps: Hybrid EMR (a mix of hot and cold techniques) and Cold EMR (no heat). The goal is to see if the hybrid method can prevent polyps from coming back without more complications.

How Is the Trial Designed?

Group I: Hybrid cold EMR Experimental Treatment 1 Intervention

Intervention group patients. Patients will receive hybrid EMR treatment.

Group II: Cold EMR Active Control 1 Intervention

Control group patients that receive standard cold EMR treatment.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11226737/

Hybrid endoscopic approaches for complex colorectal polyps ... Hybrid procedures appear to be safe and effective treatments for complex colorectal lesions not amenable to EMR, ESD or EFTR alone, because of the lesion size, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590030721000647

Hybrid APC Colon EMR, A Novel Approach to Reduce ... Endoscopic mucosal resection (EMR) has become the standard for removing large colon polyps but has a 10%-30% recurrence rate using standard techniques. Data ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(24)04935-7/fulltext

Cold Versus Hot Snare Endoscopic Resection of Large ... Cold versus hot snare endoscopic resection of large nonpedunculated colorectal polyps: randomized controlled German CHRONICLE trial.

4. withpower.com withpower.com/trial/phase-colonic-polyps-4-2025-0cb57

Cold vs Hybrid Cold EMR for Colon Polyps Cold endoscopic mucosal resection (EMR) is considered safer and more cost-effective than traditional hot EMR for large colon polyps, with fewer days of lost ...

5. gut.bmj.com gut.bmj.com/content/74/12/2124

pooled analysis of cold snare EMR for large colorectal polyps A total of 1516 LNPCPs from 1429 patients were included. Of these, 1312 lesions underwent first surveillance colonoscopy at 4–6 months of follow-up.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40029072/

Safety and Efficacy of Cold Compared With Hot ... c-EMR has a superior safety profile to h-EMR for nonpedunculated colorectal polyps ≥20 mm in size, but strategies to manage the higher odds of recurrence ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725017225

Safety and efficacy of margin and base ablation after ... EMR is the mainstay of therapy for large colorectal polyps. A previous study has shown low adverse events and recurrence rates after EMR ...

8. journals.lww.com journals.lww.com/ajg/fulltext/2025/10002/s2258_safety_and_efficacy_of_hybrid_endoscopic.2258.aspx

S2258 Safety and Efficacy of Hybrid Endoscopic ... Data on polyp characteristics and histopathology, procedural outcomes, interventions used for bleeding prophylaxis, adverse event rates, recurrence rates and ...