Thoracic
Conditions
Keywords
Surgical tissue resection, Tissue dissection, Tissue transection, Anastomosis of gastrointestina tissue
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.
Interventions
DEVICEMicrocutter XPRESS and Microcutter XCHANGE
Surgical stapling devices
Sponsors
Cardica, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- All patients requiring surgical treatment where the use of a surgical stapler is anticipated
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed