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

University of Turin

Status and phase: Not yet enrolling; Phase 4

Conditions: Colonic Dysplasia; Colonic Polyp; Colonic Neoplasms

Treatments: Procedure: EndoClot

Study type: Interventional

Funder types: Other

Identifiers

NCT02688699

12243648

Details and patient eligibility

About

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

Enrollment: 288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 2 patient groups

EndoClot

Experimental group

Description:

spraying of Endoclot powder after EMR or ESD

Treatment:

Procedure: EndoClot

control

No Intervention group