NCT01496781

EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection

EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.

Conditions

• Endoscopic Hemostasis
• Colonic Polyps

Interventions

Type	Name	Description
PROCEDURE	Hemoclip	Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
PROCEDURE	EndoClot	EndoClot hemostat is applied immediately after EMR to achieve hemostasis.

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-12-21
• Last updated: 2012-04-17

Locations

1 site across 1 country: China