Colon PolypSTARLINGNCT07198945
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
A study testing 6-month follow-up and 12-month follow-up in people with Colon Polyp and Adenoma, run by Indiana University at 10 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyp, Adenoma, Serrated Polyp
- What is being tested?
- 6-month follow-up and 12-month follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 9 Jun 2026to Feb 2030
- 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
- 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.
Show all 11Show fewer
- 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
Who cannot join
- Patient Criteria
- 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
Show all 23Show fewer
- Cowden's Syndrome
- Peutz-Jeghers Syndrome
- Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC) or Lynch Syndrome
- Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy
- 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.
- ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20).
- 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 with features of invasive cancer
- Polyps that are not able to be removed with standard endoscopic techniques for any reason
- Polyps that are incompletely resected endoscopically at index procedure
- Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United States8 sites
University of Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35244
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University
Chicago, Illinois, 60612
Henry Ford Hospital
Detroit, Michigan, 48208
Indiana University
Indianapolis, Indiana, 46202
The University of Kansas Medical Center
Kansas City, Kansas, 66221
White River Junction VA Medical Center
White River Junction, Vermont, 05009
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)
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.
- Being tested
- 6-month follow-up, 12-month follow-up
- Keywords
- Polyp Resection, Colonoscopy, Recurrence, Surveillance Interval, Patient Experience
- Medical subject headings
- Colonic Polyps, Adenoma, Neoplasm Recurrence, Local, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month follow-upProcedure or surgery
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.
12-month follow-upProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 6-month follow-up | Experimental | 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. Receives: Procedure: 6-month follow-up |
| 12-month follow-up | Experimental | 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. Receives: Procedure: 12-month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence
Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.
Measured: 1 day
Secondary outcomes (14)
Time of endoscopic management of recurrent polyp
The time it takes to treat recurrent polyp at the follow-up procedure
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At first surveillance colonoscopy, typically 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start9 Jun 2026
- Primary completionDec 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John J. Guardiola, Indiana University
- Investigators
- John J Guardiola, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198945
- Sponsor's protocol ID
- 22913
- Acronym
- STARLING
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be shared in the future upon request per PI discretion.
Publications
Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.
PubMed 32122632Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
PubMed 32044092El Rahyel A, Abdullah N, Love E, Vemulapalli KC, Rex DK. Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence. Gastroenterology. 2021 Feb;160(3):949-951.e2. doi: 10.1053/j.gastro.2020.10.039. Epub 2020 Oct 29. No abstract available.
PubMed 33130101Tate DJ, Desomer L, Argenziano ME, Mahajan N, Sidhu M, Vosko S, Shahidi N, Lee E, Williams SJ, Burgess NG, Bourke MJ. Treatment of adenoma recurrence after endoscopic mucosal resection. Gut. 2023 Oct;72(10):1875-1886. doi: 10.1136/gutjnl-2023-330300. Epub 2023 Jul 6.
PubMed 37414440Mohapatra S, Almazan E, Charilaou P, et al. Outcomes of Endoscopic Resection for Colorectal Polyps With High-Grade Dysplasia or Intramucosal Cancer. Techniques and Innovations in Gastrointestinal Endoscopy 2023;25:119-126.
Parsa N, Ponugoti P, Broadley H, Garcia J, Rex DK. Risk of cancer in 10 - 19 mm endoscopically detected colorectal lesions. Endoscopy. 2019 May;51(5):452-457. doi: 10.1055/a-0799-9997. Epub 2019 Jan 8.
PubMed 30620947McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.
PubMed 32891621Bobay MC, Lahr RE, Shultz J, Vemulapalli KC, Guardiola JJ, Rex DK. Safety of first surveillance colonoscopy at 12 months after piecemeal EMR of large nonpedunculated colorectal lesions. Gastrointest Endosc. 2024 Nov;100(5):905-913. doi: 10.1016/j.gie.2024.05.008. Epub 2024 May 14.
PubMed 38750975Lacroute J, Marcantoni J, Petitot S, Weber J, Levy P, Dirrenberger B, Tchoumak I, Baron M, Gibert S, Marguerite S, Huppertz J, Gronier O, Derlon A. The carbon footprint of ambulatory gastrointestinal endoscopy. Endoscopy. 2023 Oct;55(10):918-926. doi: 10.1055/a-2088-4062. Epub 2023 May 8.
PubMed 37156511Lopez-Munoz P, Martin-Cabezuelo R, Lorenzo-Zuniga V, Vilarino-Feltrer G, Tort-Ausina I, Vidaurre A, Pons Beltran V. Life cycle assessment of routinely used endoscopic instruments and simple intervention to reduce our environmental impact. Gut. 2023 Sep;72(9):1692-1697. doi: 10.1136/gutjnl-2023-329544. Epub 2023 Apr 26.
PubMed 37185655Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
PubMed 24671869Pohl H, Rex DK, Barber J, Moyer MT, Elmunzer BJ, Rastogi A, Gordon SR, Zolotarevsky E, Levenick JM, Aslanian HR, Elatrache M, von Renteln D, Wallace MB, Brahmbhatt B, Keswani RN, Kumta NA, Pleskow DK, Smith ZL, Abu Ghanimeh MK, Simmer S, Sanaei O, Mackenzie TA, Piraka C. Cold snare endoscopic resection for large colon polyps: a randomised trial. Gut. 2025 Oct 8;74(11):1804-1813. doi: 10.1136/gutjnl-2025-335075.
PubMed 40393701
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)
- ClinicalTrials.gov ID
- NCT07198945
- Acronym / sponsor ID
- STARLING / 22913
- Keywords
- Polyp Resection, Colonoscopy, Recurrence, Surveillance Interval, Patient Experience
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 30 Sep 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-month follow-up | Experimental | Procedure: 6-month follow-upPatients 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. |
| 12-month follow-up | Experimental | Procedure: 12-month follow-upPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (23 listed)
- Patient Criteria
- 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:
- Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy
- Patients who have any colorectal cancer by histologic diagnosis at index procedure
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 |
|---|---|---|
| 6-month follow-upEligible 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. | Procedure or surgery | 6-month follow-up |
| 12-month follow-upEligible 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. | Procedure or surgery | 12-month follow-up |
Primary outcome
Rate of recurrence
Time frame: 1 day
Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.
14 secondary outcomes
Time of endoscopic management of recurrent polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Perceived difficulty of endoscopic treatment of recurrent polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Rate of malignancy identified at first surveillance colonoscopy
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Size of recurrent polyp at first surveillance colonoscopy
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Number of distinct areas of recurrent polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Rate of high grade dysplasia identified in recurrent polyp
Time frame: After surveillance colonoscopy, typically 6 months to 12 months
Need for advanced resection techniques to treat recurrent polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Need for surgical intervention to treat recurrent polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Types of recurrences at follow-up
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Techniques used to treat recurrent polyp
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
Patient Survey Results
Time frame: Typically 1 to 14 days after the large polyp removal procedure
Adverse events that occur after the follow-up procedure
Time frame: 30 days after first surveillance colonoscopy
Distance patient travelled to the endoscopy unit
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
Time frame: At first surveillance colonoscopy, typically 6 months to 12 months
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 21 Oct 2026.
- Background: PubMed 32122632Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.
- Background: PubMed 32044092Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
- Background: PubMed 33130101El Rahyel A, Abdullah N, Love E, Vemulapalli KC, Rex DK. Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence. Gastroenterology. 2021 Feb;160(3):949-951.e2. doi: 10.1053/j.gastro.2020.10.039. Epub 2020 Oct 29. No abstract available.
- Background: PubMed 37414440Tate DJ, Desomer L, Argenziano ME, Mahajan N, Sidhu M, Vosko S, Shahidi N, Lee E, Williams SJ, Burgess NG, Bourke MJ. Treatment of adenoma recurrence after endoscopic mucosal resection. Gut. 2023 Oct;72(10):1875-1886. doi: 10.1136/gutjnl-2023-330300. Epub 2023 Jul 6.
- BackgroundMohapatra S, Almazan E, Charilaou P, et al. Outcomes of Endoscopic Resection for Colorectal Polyps With High-Grade Dysplasia or Intramucosal Cancer. Techniques and Innovations in Gastrointestinal Endoscopy 2023;25:119-126.
- Background: PubMed 30620947Parsa N, Ponugoti P, Broadley H, Garcia J, Rex DK. Risk of cancer in 10 - 19 mm endoscopically detected colorectal lesions. Endoscopy. 2019 May;51(5):452-457. doi: 10.1055/a-0799-9997. Epub 2019 Jan 8.
- Background: PubMed 32891621McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3.
- Background: PubMed 38750975Bobay MC, Lahr RE, Shultz J, Vemulapalli KC, Guardiola JJ, Rex DK. Safety of first surveillance colonoscopy at 12 months after piecemeal EMR of large nonpedunculated colorectal lesions. Gastrointest Endosc. 2024 Nov;100(5):905-913. doi: 10.1016/j.gie.2024.05.008. Epub 2024 May 14.
- Background: PubMed 37156511Lacroute J, Marcantoni J, Petitot S, Weber J, Levy P, Dirrenberger B, Tchoumak I, Baron M, Gibert S, Marguerite S, Huppertz J, Gronier O, Derlon A. The carbon footprint of ambulatory gastrointestinal endoscopy. Endoscopy. 2023 Oct;55(10):918-926. doi: 10.1055/a-2088-4062. Epub 2023 May 8.
- Background: PubMed 37185655Lopez-Munoz P, Martin-Cabezuelo R, Lorenzo-Zuniga V, Vilarino-Feltrer G, Tort-Ausina I, Vidaurre A, Pons Beltran V. Life cycle assessment of routinely used endoscopic instruments and simple intervention to reduce our environmental impact. Gut. 2023 Sep;72(9):1692-1697. doi: 10.1136/gutjnl-2023-329544. Epub 2023 Apr 26.
- Background: PubMed 24671869Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
- Background: PubMed 40393701Pohl H, Rex DK, Barber J, Moyer MT, Elmunzer BJ, Rastogi A, Gordon SR, Zolotarevsky E, Levenick JM, Aslanian HR, Elatrache M, von Renteln D, Wallace MB, Brahmbhatt B, Keswani RN, Kumta NA, Pleskow DK, Smith ZL, Abu Ghanimeh MK, Simmer S, Sanaei O, Mackenzie TA, Piraka C. Cold snare endoscopic resection for large colon polyps: a randomised trial. Gut. 2025 Oct 8;74(11):1804-1813. doi: 10.1136/gutjnl-2025-335075.
- Individual participant dataSharing planned: No. De-identified data may be shared in the future upon request per PI discretion.
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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.
John J Guardiola, MD principal investigator
Indiana University
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-month follow-up and 12-month follow-up in people with Colon Polyp and Adenoma, run by Indiana University at 10 sites in 3 countries.
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 11 inclusion and 23 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: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Slovenia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198945, which also lists 12 linked publications.
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 21 Oct 2026.