Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT01476761
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2011-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MicroCutter in Surgical Stapling - European Trial I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2011-11-18', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite adverse event rate', 'timeFrame': 'up to 30 days postoperatively', 'description': 'Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Surgical tissue resection', 'Tissue dissection', 'Tissue transection', 'Anastomosis of gastrointestina tissue'], 'conditions': ['Thoracic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cardica.com', 'label': 'Manufacturer of MicroCutter'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All patients requiring surgical treatment where the use of a surgical stapler is anticipated\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT01476761', 'acronym': 'MET1', 'briefTitle': 'MicroCutter in Surgical Stapling - European Trial I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardica, Inc'}, 'officialTitle': 'The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study', 'orgStudyIdInfo': {'id': 'CP 2011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MicroCutter Stapling Device', 'description': 'Patients undergoing surgical treatment with the MicroCutter Stapling Device', 'interventionNames': ['Device: Microcutter XPRESS and Microcutter XCHANGE']}], 'interventions': [{'name': 'Microcutter XPRESS and Microcutter XCHANGE', 'type': 'DEVICE', 'otherNames': ['MicroCutter XPRESS30', 'MicroCutter XPRESS45', 'MicroCutter XCHANGE30'], 'description': 'Surgical stapling devices', 'armGroupLabels': ['MicroCutter Stapling Device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanover', 'country': 'Germany', 'facility': 'DRK-Krankenahus Clementinenhaus', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Andreas Kithe, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DRK-Krankenhaus Clementinenhaud, Hannover'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardica, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}