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NCT03462706

Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

Completed NA Results posted Last updated 15 February 2023
What this trial tests

NA trial testing Cold Snare in Colon Cancer in 238 participants. Completed in 14 May 2021.

Timeline
6 February 2018
Primary endpoint
14 May 2021
14 May 2021

Quick facts

Lead sponsorIndiana University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment238
Start date6 February 2018
Primary completion14 May 2021
Estimated completion14 May 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Indiana University

Who can join

40 and older, any sex, with Colon Cancer or Colon Polyp. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Efficacy of Resection (Central Post-Resection Biopsies) Primary · 1 day

Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome.

Negative
GroupValue95% CI
Cold Snare68
Cold EMR82
Hot Snare69
Hot EMR63
Positive
GroupValue95% CI
Cold Snare0
Cold EMR0
Hot Snare2
Hot EMR2
Efficacy of Resection (Peripheral Post-Resection Biopsies) Primary · 1 day

Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome.

Negative
GroupValue95% CI
Cold Snare68
Cold EMR81
Hot Snare70
Hot EMR62
Positive
GroupValue95% CI
Cold Snare0
Cold EMR1
Hot Snare1
Hot EMR3

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cold Snare
Serious: 0/59 (0%)
Deaths: 0/59
Cold EMR
Serious: 0/63 (0%)
Deaths: 0/63
Hot Snare
Serious: 1/57 (2%)
Deaths: 0/57
Hot EMR
Serious: 1/56 (2%)
Deaths: 0/56

Serious adverse events (1 terms)

ReactionSystemCold SnareCold EMRHot SnareHot EMR
delayed hemorrhageInjury, poisoning and procedural complications
Other adverse events (7 terms — click to expand)

ReactionSystemCold SnareCold EMRHot SnareHot EMR
Abdominal painInjury, poisoning and procedural complications
Intraprocedural bleed from biopsyInjury, poisoning and procedural complications
Delayed BleedInjury, poisoning and procedural complications
Urinary incontinence or retentionInjury, poisoning and procedural complications
Bowel Movement IrregularityInjury, poisoning and procedural complications
Medication ReactionInjury, poisoning and procedural complications
Other, MiscellaneousInjury, poisoning and procedural complications

Most-reported serious reactions: delayed hemorrhage.

Data from ClinicalTrials.gov NCT03462706 adverse events section.

Sponsor's own description

The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cold versus hot snare resection with or without submucosal injection of 6- to 15-mm colorectal polyps: a randomized controlled trial.
    Rex DK, Anderson JC, Pohl H, Lahr RE, et al · · 2022 · cited 47× · PMID 35288147 · DOI 10.1016/j.gie.2022.03.006

Verify or expand the search:

Other recruiting trials for Colon Cancer

Currently open trials in the same condition.

Other Indiana University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03462706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing