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NCT02688699 Clinical Trial

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

Colonic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02688699
Other study ID # 12243648
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 2023
Est. completion date March 2024

Study information
Verified date May 2023
Source University of Turin, Italy
Contact Alberto Arezzo, MD
Phone +393358378243
Email alberto.arezzo@unito.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 288
Est. completion date March 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Turin, Italy

Outcome
Type Measure Description Time frame Safety issue
Primary 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 14 days
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