Polyp of ColonNCT06937671
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
A study testing Cold EMR and Hybrid EMR in people with Polyp of Colon and Endoscopic Mucosal Resection, run by The Cleveland Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Colon, Endoscopic Mucosal Resection
- What is being tested?
- Cold EMR and Hybrid EMR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Madhusudhan Sanaka, M.D.
Madhusudhan Sanaka, M.D.
- Recruiting
Cleveland Clinic Weston
Weston, Florida, 33331
Akram Ahmad, M.D., 954-659-5000, ahmada5@ccf.org
Michael Nicolas, B.S., 954-659-6213, nicolam4@ccf.org
About this study
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.
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection
- Being tested
- Cold EMR, Hybrid EMR
- Keywords
- EMR, Cold EMR, Hybrid EMR, Endoscopic mucosal resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold EMRProcedure or surgery
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
Hybrid EMRProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold EMR | Active comparator | Control group patients that receive standard cold EMR treatment. Receives: Procedure: Cold EMR |
| Hybrid cold EMR | Experimental | Intervention group patients. Patients will receive hybrid EMR treatment. Receives: Procedure: Hybrid EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of polyps
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Measured: 3-6 months after the procedure
Secondary outcomes (4)
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
Measured: 3-6 months after the procedure
Polyp recurrence rates
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
Measured: 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.
Measured: 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
Measured: 3-6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of ColonStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shah,Tilak, The Cleveland Clinic
- Investigators
- Tilak Shah, M.D., Principal investigator, Cleveland Clinic Florida (Weston Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937671
- Sponsor's protocol ID
- 25-126
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
- ClinicalTrials.gov ID
- NCT06937671
- Acronym / sponsor ID
- 25-126
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection
- Keywords
- EMR, Cold EMR, Hybrid EMR, Endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold EMR | Active comparator | Procedure: Cold EMRControl group patients that receive standard cold EMR treatment. |
| Hybrid cold EMR | Experimental | Procedure: Hybrid EMRIntervention group patients. Patients will receive hybrid EMR treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold EMRCold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared. | Procedure or surgery | Cold EMR |
| Hybrid EMRCold 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. | Procedure or surgery | Hybrid cold EMR |
Primary outcome
Recurrence of polyps
Time frame: 3-6 months after the procedure
Recurrence of polyps confirmed by biopsy at the site of EMR on follow-up colonoscopy
4 secondary outcomes
Adverse events
Time frame: 3-6 months after the procedure
Polyp recurrence rates
Time frame: 3-6 months after EMR procedure
Cost benefit analysis
Time frame: 3-6 months after the procedure
Subgroup polyp recurrence rate
Time frame: 3-6 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tilak Shah, M.D. principal investigator
Cleveland Clinic Florida (Weston Hospital)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold EMR and Hybrid EMR in people with Polyp of Colon and Endoscopic Mucosal Resection, run by The Cleveland Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akram Ahmad, M.D. (954-659-5000, ahmada5@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of polyps (time frame: 3-6 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.