An interventional study of 6-month follow-up and 12-month follow-up in Colon Polyp, Adenoma and Serrated Polyp, sponsored by Indiana University. Enrolling by invitation at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Indiana University · Not applicable, Interventional, and Prevention
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 546 is above the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 21, 2026. See what changed
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.
Patient Criteria
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
Histology without high grade dysplasia:
Exclusion Criteria:
Patient Criteria
Patients with a known or suspected diagnosis of any of the following polyposis or non-polyposis syndromes with known genetic mutations:
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
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be recommended to complete their first surveillance procedure 6 months after the large polyp removal procedure in order to assess whether the polyp grew back.
Procedure: 6-month follow-up
Patients will be recommended to complete their first surveillance procedure 12 months after the large polyp removal procedure in order to assess whether the polyp grew back.
Procedure: 12-month follow-up
Eligible patients randomized to the 6-month follow-up arm will undergo their first surveillance procedure 6 months after the removal of their large polyp to check for recurrent polyp tissue.
Eligible patients randomized to the 12-month follow-up arm will undergo their first surveillance procedure 12 months after the removal of their large polyp to check for recurrent polyp tissue.
Rate of recurrence
Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.
Time frame: 1 day
Time of endoscopic management of recurrent polyp
The time it takes to treat recurrent polyp at the follow-up procedure
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Perceived difficulty of endoscopic treatment of recurrent polyp
Perceived difficulty of endoscopic treatment of recurrent polyp will be assessed by the endoscopist based at the follow-up procedure on Likert scale 1 - 5 from very difficult to very easy.
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Rate of malignancy identified at first surveillance colonoscopy
The rate of malignancy measured at the first follow-up colonoscopy
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Size of recurrent polyp at first surveillance colonoscopy
The size of recurrent polyp tissue as measured by maximum size in millimeters
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Number of distinct areas of recurrent polyp
The number of areas of recurrent polyp tissue identified at the site of the prior large polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Rate of high grade dysplasia identified in recurrent polyp
The rate of high grade dysplasia identified in recurrent polyp tissue.
Time frame: After surveillance colonoscopy, typically 6 months to 12 months
Need for advanced resection techniques to treat recurrent polyp
Whether advanced techniques (such as the use of endoscopic submucosal dissection or full thickness resection device) are needed to treat recurrent polyp tissue
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Need for surgical intervention to treat recurrent polyp
Whether surgical intervention is needed to treat recurrent polyp tissue
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Types of recurrences at follow-up
Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology.
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Techniques used to treat recurrent polyp
The different techniques that were used to treat the recurrent polyp tissue.
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Patient Survey Results
Patient reported experience, including patient's comfort level with prolonged index surveillance, likelihood for returning for follow-up colonoscopy with extended interval, and other factors. This survey is multiple questions, and the responses will be reported on a 5-point Likert scale with 1 being very uncomfortable, not at all important, etc to 5 being very comfortable, very important, etc.
Time frame: Typically 1 to 14 days after the large polyp removal procedure
Adverse events that occur after the follow-up procedure
The number of complications for each randomization arm during and after the follow-up procedure
Time frame: 30 days after first surveillance colonoscopy
Distance patient travelled to the endoscopy unit
Calculation of the distance the patient travelled to the endoscopy unit as a surrogate for carbon impact
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Cost of equipment used at the resection site during the follow-up colonoscopy
The cost of the equipment that was used at the resection site during the surveillance procedure
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Plan to share: No — De-identified data may be shared in the future upon request per PI discretion.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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