MicroCutter in Surgical Stapling - European Trial I

Phase 4

Completed

• Conditions: Thoracic
• Interventions: Device: Microcutter XPRESS and Microcutter XCHANGE

• Registration Number: NCT01476761
• Lead Sponsor: Cardica, Inc

Brief 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-07
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• All patients requiring surgical treatment where the use of a surgical stapler is anticipated

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MicroCutter Stapling Device	Microcutter XPRESS and Microcutter XCHANGE	Patients undergoing surgical treatment with the MicroCutter Stapling Device

Primary Outcome Measures

Name	Time	Method
Composite adverse event rate	up to 30 days postoperatively	Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection

Trial Locations

Locations (1)

DRK-Krankenahus Clementinenhaus; 🇩🇪 Hannover, Germany