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Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract

Primary Purpose

Colonic Polyp, Colonic Neoplasms, Colonic Dysplasia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
EndoClot
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years old
  • lesions suitable for EMR or ESD
  • > 20 mm
  • site in the right colon

Exclusion Criteria:

  • Severe cardiovascular pathologies
  • Liver and Urinary dysfunctions
  • Hematologic diseases
  • Pregnancy and breast feeding
  • impossible follow-up
  • platelet and coagulation disorders (PLT < 50 x 109/L, INR > 2)
  • Sensitivity or allergy to the drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    EndoClot

    control

    Arm Description

    spraying of Endoclot powder after EMR or ESD

    Outcomes

    Primary Outcome Measures

    effectiveness of EndoClotTM in preventing post-procedural bleeding
    The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    May 13, 2023
    Sponsor
    University of Turin, Italy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02688699
    Brief Title
    Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
    Official Title
    Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Turin, Italy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Polyp, Colonic Neoplasms, Colonic Dysplasia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    288 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EndoClot
    Arm Type
    Experimental
    Arm Description
    spraying of Endoclot powder after EMR or ESD
    Arm Title
    control
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    EndoClot
    Intervention Description
    All patients enrolled and submitted to EMR or ESD in several units of Italian endoscopy will be divided into two different groups: in a first group will be included patients at the endoscopic end of which will be applied EndoClotTM based on the lesion removed in addition to the treatment Standard (drug injection, electrocoagulation, metal clips). The second group, on the other hand, includes patients in whom EndoClotTM will not be used. Before the end of the procedure neither the endoscopist nor the patient will know the group because the group to which the patient is assigned will be written in a sealed envelope that will be opened only at the end of the procedure before the endoscope extraction: The use of EndoClotTM will depend on the group to which the patient belongs.
    Primary Outcome Measure Information:
    Title
    effectiveness of EndoClotTM in preventing post-procedural bleeding
    Description
    The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >18 years old lesions suitable for EMR or ESD > 20 mm site in the right colon Exclusion Criteria: Severe cardiovascular pathologies Liver and Urinary dysfunctions Hematologic diseases Pregnancy and breast feeding impossible follow-up platelet and coagulation disorders (PLT < 50 x 109/L, INR > 2) Sensitivity or allergy to the drug
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alberto Arezzo, MD
    Phone
    +393358378243
    Email
    alberto.arezzo@unito.it

    12. IPD Sharing Statement

    Learn more about this trial

    Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract

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