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

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ClinicalTrials.gov Identifier: NCT02688699
Recruitment Status : Not yet recruiting
First Posted : February 23, 2016
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Alberto Arezzo, University of Turin, Italy

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

Condition or disease Intervention/treatment Phase
Colonic Polyp Colonic Neoplasms Colonic Dysplasia Procedure: EndoClot Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: EndoClot
spraying of Endoclot powder after EMR or ESD
Procedure: EndoClot

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.


No Intervention: control



Primary Outcome Measures :
  1. effectiveness of EndoClotTM in preventing post-procedural bleeding [ Time Frame: 14 days ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688699


Contacts
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Contact: Alberto Arezzo, MD +393358378243 alberto.arezzo@unito.it

Sponsors and Collaborators
University of Turin, Italy
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Responsible Party: Alberto Arezzo, Associate Professor of Surgery, MD, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02688699    
Other Study ID Numbers: 12243648
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases