RECRUITING

Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.

Quick Facts

Study Start:2025-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06937671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patient (age 18 years or older)
  2. * Polyp size of at least 20 mm
  3. * - Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above)
  1. * Polyps with previous failed resection attempts or polyp recurrence
  2. * Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma)
  3. * Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare
  4. * Inflammatory bowel disease

Contacts and Locations

Study Contact

Akram Ahmad, M.D.
CONTACT
954-659-5000
ahmada5@ccf.org
Michael Nicolas, B.S.
CONTACT
9546596213
nicolam4@ccf.org

Principal Investigator

Tilak Shah, M.D.
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida (Weston Hospital)

Study Locations (Sites)

Cleveland Clinic Weston
Weston, Florida, 33331
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Tilak Shah, M.D., PRINCIPAL_INVESTIGATOR, Cleveland Clinic Florida (Weston Hospital)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • EMR
  • Cold EMR
  • Hybrid EMR
  • Endoscopic mucosal resection

Additional Relevant MeSH Terms

  • Polyp of Colon
  • Endoscopic Mucosal Resection