ClinicalTrials.gg
Enrolling by invitationNCT06462521CARDINALUpdated Oct 21, 2026

Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

An interventional study of Cold Snare Piecemeal Resection (CSPR) and Cold Snare Endoscopic Mucosal Resection (Cold EMR) in Colon Polyp, Colon Adenoma and Serrated Polyp, sponsored by Indiana University. Enrolling by invitation at 9 sites in 2 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

Updated Oct 21, 2026First site in Canada9 sites added+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
570
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.

02

Conditions studied

  • Colon Polyp
  • Colon Adenoma
  • Serrated Polyp

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Keywords

  • Polyp Resection
  • Cold Snare
  • Cold Endoscopic Mucosal Resection (Cold EMR)
  • Cold Snare Piecemeal Resection (CSPR)
  • Colonoscopy
03

In context

Colonic Polyps

377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.

This study's planned enrollment of 570 is above the median of 274 across 250 interventional studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. ≥ 18 years of age
  2. Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
  3. Found to have:

    • a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or
    • a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
  4. Ability to provide

Exclusion criteria

Exclusion Criteria:

  1. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
  2. Polyps confirmed to be anything other than:

    • sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or
    • conventional adenoma on histologic diagnosis (Adenoma Cohort)
  3. Patients with Ulcerative Colitis or Crohn's disease
  4. Polyps with features suggestive of submucosal invasion
  5. Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
  6. Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:

    • Familial Adenomatous Polyposis Syndrome
    • MUTYH associated Polyposis Syndrome
    • Juvenile Polyposis Syndrome
    • Cowden's Syndrome
    • Peutz-Jeghers Syndrome
  7. Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
570 participants (estimated)

Study arms

  • Experimental
    Cold Snare Piecemeal Resection (CSPR)

    Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using CSPR technique.

    Procedure: Cold Snare Piecemeal Resection (CSPR)

  • Experimental
    Cold Snare Endoscopic Mucosal Resection (Cold EMR)

    Conventional adenomas sized 10-19mm or serrated lesions 10mm or larger found during colonoscopy will be removed using Cold EMR technique.

    Procedure: Cold Snare Endoscopic Mucosal Resection (Cold EMR)

Interventions

  • ProcedureCold Snare Piecemeal Resection (CSPR)

    Qualifying polyps randomized to Cold Snare Piecemeal Resection (CSPR) will be removed using cold snare techniques (no electrocautery, no submucosal injection.)

  • ProcedureCold Snare Endoscopic Mucosal Resection (Cold EMR)

    Qualifying polyps randomized to Cold Snare Endoscopic Mucosal Resection (Cold EMR) will be removed using cold snare techniques (no electrocautery, with submucosal injection.)

06

What researchers measure

Primary outcomes

  1. Efficacy of Resection (Central Post-Resection Biopsies)

    Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.

    Time frame: 1 day

  2. Efficacy of Resection (Peripheral Post-Resection Biopsies)

    Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR.

    Time frame: 1 day

Secondary outcomes

  1. Polyp Resection Time

    The time it takes to remove the polyp completely

    Time frame: 1 day

  2. Resection Preparation Time

    The time it takes to prepare for polyp removal

    Time frame: 1 day

  3. Total Procedure Time

    The total time it takes to complete the colonoscopy procedure

    Time frame: 1 day

  4. Adverse Events

    The number of complications for each randomization arm during and after the procedure

    Time frame: 30 Days

  5. Rate of Recurrence at First Surveillance Colonoscopy for Polyps ≥ 20mm

    The recurrence rate of serrated lesions ≥ 20mm measured at the first follow-up colonoscopy

    Time frame: At first surveillance colonoscopy, typically 6 months to 12 months

07

Study locations

9 sites
08

References and documents

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 32122632 ↗
  • von Renteln D, Djinbachian R, Benard F, Barkun AN, Bouin M, Bouchard S, Deslandres E, Panzini B, Sidani S, Leduc R, Jobse BC, Pohl H. Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors. Endoscopy. 2023 Oct;55(10):929-937. doi: 10.1055/a-1978-3277. Epub 2022 Nov 14. PubMed 36377124 ↗
  • McWhinney 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 32891621 ↗
  • Rex DK, Anderson JC, Pohl H, Lahr RE, Judd S, Antaki F, Lilley K, Castelluccio PF, Vemulapalli KC. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2022 Aug;96(2):330-338. doi: 10.1016/j.gie.2022.03.006. Epub 2022 Mar 12. PubMed 35288147 ↗
  • Kimoto Y, Sakai E, Inamoto R, Kurebayashi M, Takayanagi S, Hirata T, Suzuki Y, Ishii R, Konishi T, Kanda K, Negishi R, Takita M, Ono K, Minato Y, Muramoto T, Ohata K. Safety and Efficacy of Cold Snare Polypectomy Without Submucosal Injection for Large Sessile Serrated Lesions: A Prospective Study. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e132-e138. doi: 10.1016/j.cgh.2020.10.053. Epub 2020 Nov 2. PubMed 33152541 ↗
  • Mangira D, Raftopoulos S, Vogrin S, Hartley I, Mack A, Gazelakis K, Nalankilli K, Trinh A, Metz AJ, Appleyard M, Grimpen F, Elliott T, Brown G, Moss A. Effectiveness and safety of cold snare polypectomy and cold endoscopic mucosal resection for nonpedunculated colorectal polyps of 10-19 mm: a multicenter observational cohort study. Endoscopy. 2023 Jul;55(7):627-635. doi: 10.1055/a-2029-9539. Epub 2023 Feb 7. PubMed 36750222 ↗
  • Gupta 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 32044092 ↗

Individual participant data

Plan to share: No — De-identified data may be shared in the future upon request per PI discretion.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Jul 2027, 34 months after the start.

Of 132 non-industry interventional studies with no phase under Colonic Polyps, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 34 months is above that.

Counting every sponsor, half of 149 studies reached it within 17 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2024
First posted
Jun 17, 2024
StartActual
Sep 6, 2024
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2028
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
9 sites added, 1 site removed — first site in Canada
Show 9 added (7 United States, 2 Canada)
  • University of Alabama at Birmingham · Birmingham, United States
  • University of Colorado · Aurora, United States
  • Rush University · Chicago, United States
  • IU Health University Hospital · Indianapolis, United States
  • The University of Kansas Medical Center · Kansas City, United States
  • John D. Dingell VA Medical Center · Detroit, United States
  • White River Junction VA Medical Center · White River Junction, United States
  • University of British Columbia · Vancouver, Canada
  • Centre hospitalier de l'Université de Montréal (CHUM) · Montreal, Canada
Show 1 removed
  • Indiana University · Indianapolis, United States
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    9 sites added, 1 site removed — first site in Canada
    Show 9 added (7 United States, 2 Canada)
    • University of Alabama at Birmingham · Birmingham, United States
    • University of Colorado · Aurora, United States
    • Rush University · Chicago, United States
    • IU Health University Hospital · Indianapolis, United States
    • The University of Kansas Medical Center · Kansas City, United States
    • John D. Dingell VA Medical Center · Detroit, United States
    • White River Junction VA Medical Center · White River Junction, United States
    • University of British Columbia · Vancouver, Canada
    • Centre hospitalier de l'Université de Montréal (CHUM) · Montreal, Canada
    Show 1 removed
    • Indiana University · Indianapolis, United States
    + 4 other changes: verification date, responsible party, conditions and index terms

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 ↗

10

Registry details

Key details

Study ID
NCT06462521
Lead sponsor
Indiana University
Responsible party
John J. Guardiola (Assistant Professor of Clinical Medicine, Indiana University) — Principal investigator
First posted
Jun 17, 2024
Start date
Sep 6, 2024
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

John J Guardiola, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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