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

May 13, 2023 updated by: Alberto Arezzo, University of Turin, Italy

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 13, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12243648

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonic Polyp

Clinical Trials on EndoClot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe