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

Sponsor
University of Turin, Italy (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02688699
Collaborator
(none)
288
Enrollment
2
Arms
5.9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: EndoClot
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. effectiveness of EndoClotTM in preventing post-procedural bleeding [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Turin, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alberto Arezzo, Associate Professor of Surgery, MD, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT02688699
Other Study ID Numbers:
  • 12243648
First Posted:
Feb 23, 2016
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Polyps

Study Results

No Results Posted as of Apr 28, 2021