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

Phase 4

Not yet recruiting

• Conditions: Colonic Polyp; Colonic Neoplasms; Colonic Dysplasia
• Interventions: Procedure: EndoClot

• Registration Number: NCT02688699
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16
• Study Start: 2023-09
• Primary Completion: 2024-02
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 288

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EndoClot	EndoClot	spraying of Endoclot powder after EMR or ESD

Primary Outcome Measures

Name	Time	Method
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