MicroCutter in Surgical Stapling - European Trial I (MET1)
| Tracking Information | |||||
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| First Received Date ICMJE | November 18, 2011 | ||||
| Last Updated Date | November 29, 2011 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Composite adverse event rate [ Time Frame: up to 30 days postoperatively ] [ Designated as safety issue: Yes ] Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01476761 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MicroCutter in Surgical Stapling - European Trial I | ||||
| Official Title ICMJE | The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Thoracic | ||||
| Intervention ICMJE | Device: Microcutter XPRESS and Microcutter XCHANGE
Surgical stapling devices
Other Names:
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| Study Arm (s) | Active Comparator: MicroCutter Stapling Device
Patients undergoing surgical treatment with the MicroCutter Stapling Device
Intervention: Device: Microcutter XPRESS and Microcutter XCHANGE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 178 | ||||
| Estimated Completion Date | April 2013 | ||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - All patients requiring surgical treatment where the use of a surgical stapler is anticipated Exclusion Criteria: - None |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01476761 | ||||
| Other Study ID Numbers ICMJE | CP 2011-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Cardica, Inc | ||||
| Study Sponsor ICMJE | Cardica, Inc | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Cardica, Inc | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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