NCT02688699

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colonic Polyp
• Colonic Neoplasms
• Colonic Dysplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-02-01
• Completion: 2024-03-01
• First posted: 2016-02-23
• Last updated: 2023-05-16