Thoracic Clinical Trial
— MET1Official title:
The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study
Verified date | August 2013 |
Source | Cardica, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | July 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients requiring surgical treatment where the use of a surgical stapler is anticipated Exclusion Criteria: - None |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | DRK-Krankenahus Clementinenhaus | Hannover |
Lead Sponsor | Collaborator |
---|---|
Cardica, Inc |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite adverse event rate | Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection | up to 30 days postoperatively | Yes |
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