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Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation

NCT04063280

Description:

A multi-center randomized controlled trial in only 24 patients showed a significant reduction of the recurrence rate by treatment of the normal appearing perimeter of the EMR defect using the argon plasma coagulator (2). A recent non-randomized trial suggested a substantial reduction by treatment of the perimeter with the snare tip in the soft coagulation mode (3).

Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation
  • Official Title: Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation

Clinical Trial IDs

  • ORG STUDY ID: 19-00807
  • NCT ID: NCT04063280

Conditions

  • Colon Polyp

Purpose

A multi-center randomized controlled trial in only 24 patients showed a significant reduction of the recurrence rate by treatment of the normal appearing perimeter of the EMR defect using the argon plasma coagulator (2). A recent non-randomized trial suggested a substantial reduction by treatment of the perimeter with the snare tip in the soft coagulation mode (3).

Detailed Description

      The previous study using STSC was a non-randomized trial. In this trial investigators hope to
      provide definitive evidence regarding the efficacy of APC and STSC vs control. It is
      hypothesized that Argon Plasma Coagulation (APC) or Snare Tip Soft Coagulation (STSC)
      treatment of the perimeter of the Endoscopic mucosal resection (EMR) defect will reduce the
      recurrence rate of adenomas when compared to our control of no treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Snare Tip Soft Coagulation (STSC)Experimental
    Argon Plasma Coagulation (APC)Active Comparator
      No TreatmentNo Intervention

        Eligibility Criteria

                Inclusion Criteria:
        
                  -  Ability to provide informed consent
        
                  -  Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of
                     a lesion
        
                Exclusion Criteria:
        
                  -  Pedunculated lesions
        
                  -  Inflammatory bowel disease
        
                  -  Inability to provide informed consent
        
                  -  Lesions less than 15mm in largest dimension
              
        Maximum Eligible Age:99 Years
        Minimum Eligible Age:25 Years
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Recurrence rate of adenomas
        Time Frame:24 Months
        Safety Issue:
        Description:the recurrence rate of adenomas at the site of any qualifying, previously resected lesions at the 6-month follow-up colonoscopy.

        Secondary Outcome Measures

        Measure:Time
        Time Frame:1 Day
        Safety Issue:
        Description:During the colonoscopy the treatment time will be recorded as the time, after initial polyp resection, that the randomized treatment instrument comes into view until before clips are applied
        Measure:Number of complications for each randomization arm
        Time Frame:30 Days
        Safety Issue:
        Description:Complications will be assessed during the follow-up call simply by asking the patients if they experienced any adverse events.

        Details

        Phase:N/A
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:NYU Langone Health

        Trial Keywords

        • Endoscopic mucosal resection

        Last Updated

        August 10, 2020