MicroCutter in Surgical Stapling - European Trial I (MET1)

Cardica

Status and phase: Completed; Phase 4

Conditions: Thoracic

Treatments: Device: Microcutter XPRESS and Microcutter XCHANGE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476761

CP 2011-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

MicroCutter Stapling Device

Active Comparator group

Description:

Patients undergoing surgical treatment with the MicroCutter Stapling Device

Treatment:

Device: Microcutter XPRESS and Microcutter XCHANGE