NCT01306877

Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DEVICE	EEA Hemorrhoid and Prolapse Stapling Set	Surgical device
DEVICE	Endosurgery Proximate PPH03 Stapling Set	Surgical device

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-08-01
• Completion: 2013-01-01
• First posted: 2011-03-02
• Last updated: 2014-10-29
• Results posted: 2014-10-29

Locations

1 site across 1 country: United States