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
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Colonic Dysplasia
• Colonic Neoplasms
• Colonic Polyp
• Colonic Polyps

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