Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00957502
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2009-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ENTact™ Septal Stapler Shelf Life Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2009-08-11', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance of aged ENTact™ Septal Staples', 'timeFrame': 'One week post op'}], 'secondaryOutcomes': [{'measure': 'Clinical evaluation of gross tissue appearance at implantation site(s)', 'timeFrame': 'One week post op'}, {'measure': 'ENTact™ Septal Staple functionality based on maintained coaptation', 'timeFrame': 'One week post op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Deviated Nasal Septum']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.\n* Patient is able to provide a signed informed consent form.\n* Patient will agree to comply with all study related procedures.\n* Subject is not pregnant at this time by confirmation of one of the following:\n\n * subject is male,\n * subject not of child bearing age,\n * subject is surgically sterile,\n * subject is not pregnant per negative hCG test.\n* Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.\n\nExclusion Criteria:\n\n* Patients who have had previous septoplasty\n* Patients with uncontrolled diabetes\n* Presence of infection at the study site\n* Subject is a:\n\n * smoker,\n * severe drug abuser,\n * severe alcohol abuser.\n* Patient with autoimmune disease deemed clinically significant by the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT00957502', 'acronym': 'SSLE', 'briefTitle': 'ENTact™ Septal Stapler Shelf Life Extension', 'organization': {'class': 'INDUSTRY', 'fullName': 'ENTrigue Surgical, Inc.'}, 'officialTitle': 'A Prospective, Limited-Use Evaluation of the ENTact™ Septal Stapler for Tissue Approximation Utilizing Staples With Extended Shelf Life', 'orgStudyIdInfo': {'id': 'CSA2009-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One year aged staples', 'description': 'Subjects implanted with sterile staples aged to approximately one year.', 'interventionNames': ['Device: ENTact™ Septal Stapler']}, {'type': 'EXPERIMENTAL', 'label': '18 month aged staples', 'description': 'Subjects implanted with sterile staples aged to approximately 18 months.', 'interventionNames': ['Device: ENTact™ Septal Stapler']}], 'interventions': [{'name': 'ENTact™ Septal Stapler', 'type': 'DEVICE', 'description': '1 year aged septal staples', 'armGroupLabels': ['One year aged staples']}, {'name': 'ENTact™ Septal Stapler', 'type': 'DEVICE', 'description': '18 Month Aged Staples', 'armGroupLabels': ['18 month aged staples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Thomas A Tami, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Good Samaritan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ENTrigue Surgical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}