NCT07198945Enrolling by invitation
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
The study will compare the use of a 6-month follow-up vs a 12-month follow-up after the removal of a large non-pedunculated polyp 20-50mm in size and without high grade dysplasia.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 546 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- 9 Jun 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Indiana University
- NCT number
- NCT07198945
What you commit to
- Study type: Interventional
- Planned participants: 546
- From 9 Jun 2026 to the primary completion date, Dec 2029
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)
Other illness
- Patients with confirmed diagnosis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease.
- Patients with a known or suspected diagnosis of any of the following polyposis or non-polyposis syndromes with known genetic mutations:
- Familial Adenomatous Polyposis Syndrome
- MUTYH associated Polyposis Syndrome
- Juvenile Polyposis Syndrome
- Cowden's Syndrome
- Peutz-Jeghers Syndrome
- Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC) or Lynch Syndrome
- Patients who have any colorectal cancer by histologic diagnosis at index procedure
- Patients needing a colonoscopy 6 months or sooner for any indication following the index procedure including burden of synchronous disease, inadequate prep to assess for synchronous disease, inadequate prep that precludes resection of index large polyp, or other reason limiting ability to complete full examination of colon at time of resection.
- Polyps with features of invasive cancer
Lab values
- ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20).
Other
- Patient Criteria
- Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy
- Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy
- Patients with significant medical problems that could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study per the judgement of the investigator.
- Polyp Criteria
- Polyp located at appendiceal orifice, ileocecal valve, or intradiverticulum
- Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- A polyp that is classified as a traditional serrated adenoma.
- Polyps that are not able to be removed with standard endoscopic techniques for any reason
- Polyps that are incompletely resected endoscopically at index procedure
Who the study is looking for
- Patient Criteria
- ≥ 18 years of age
- Ability to provide informed consent
- Willing and able to complete one electronic survey
- Presenting for colonoscopy for any indication
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments.
- Polyp Criteria
- Size 20-50 mm as documented with photo containing open snare of known size as comparison.
- Histology without high grade dysplasia:
- Conventional Adenoma: adenoma with or without villous components
- Serrated: hyperplastic or sessile serrated lesion
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| RUSH University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| The University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| White River Junction VA Medical Center Coordinator of this site? Confirm its status | White River Junction | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.