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

U

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

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

Trial contacts and locations

0

Loading...

Central trial contact

Alberto Arezzo, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems