NCT01476761

MicroCutter in Surgical Stapling - European Trial I

The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Cardica, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.

Detailed description

A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.

Conditions

• Thoracic

Interventions

Type	Name	Description
DEVICE	Microcutter XPRESS and Microcutter XCHANGE	Surgical stapling devices

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2011-11-22
• Last updated: 2013-08-09

Locations

1 site across 1 country: Germany