Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-04-23 @ 12:56 PM
Study NCT ID:
NCT02304692
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2014-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Survey of Different Abutment Topologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006314', 'term': 'Hearing Loss, Conductive'}, {'id': 'D046089', 'term': 'Hearing Loss, Mixed Conductive-Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skin status according to Holgers and clinical assessment', 'timeFrame': '3 months post surgery'}, {'measure': 'Skin status according to Holgers and clinical assessment', 'timeFrame': 'Up to 24 months post surgery'}, {'measure': 'Postoperative complications', 'timeFrame': '3 months post surgery'}, {'measure': 'Pain and numbness', 'timeFrame': 'Up to 24 months post surgery'}, {'measure': 'Implant stability by clinical assessment and implant stability quotient (ISQ)measurements', 'timeFrame': 'Up to 24 months post surgery'}, {'measure': 'Pocket depth', 'timeFrame': '6 months post surgery'}], 'primaryOutcomes': [{'measure': 'Number of colony forming units (CFU)', 'timeFrame': '3 months post-surgery', 'description': 'The primary end point is CFU counts 3 months post-surgery.'}], 'secondaryOutcomes': [{'measure': 'Number of colony forming units (CFU) on abutment (CFU/abutment)', 'timeFrame': '3 months post-surgery'}, {'measure': 'Number of colony forming units (CFU) on abutment (CFU/abutment)', 'timeFrame': '12 months post-surgery'}, {'measure': 'Number of colony forming units (CFU), strip (CFU/strip)', 'timeFrame': '3 months post-surgery'}, {'measure': 'Number of colony forming units (CFU), strip (CFU/strip)', 'timeFrame': '12 months post-surgery'}, {'measure': 'Number of colony forming units (CFU) in tissue samples (CFU/mg', 'timeFrame': '3 months post-surgery'}, {'measure': 'Number of colony forming units (CFU) in tissue samples (CFU/mg', 'timeFrame': '12 months post-surgery'}, {'measure': 'RNA level for host inflammatory response', 'timeFrame': '3 months post-surgery'}, {'measure': 'RNA level for tissue repair', 'timeFrame': '3 months post-surgery'}, {'measure': 'RNA level for host host microbial infection response', 'timeFrame': '3 months post-surgery'}, {'measure': 'RNA level for host inflammatory response', 'timeFrame': '12 months post-surgery'}, {'measure': 'RNA level for tissue repair', 'timeFrame': '12 months post-surgery'}, {'measure': 'RNA level for host host microbial infection response', 'timeFrame': '12 months post-surgery'}, {'measure': 'Histology investigation of tissue biopsy', 'timeFrame': '3 months post-surgery'}, {'measure': 'Histology investigation of tissue biopsy', 'timeFrame': '12 months post-surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Conductive Hearing Loss', 'Unilateral Partial Deafness', 'Mixed Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare two different surfaces of bone anchored hearing aid abutments in terms of bacterial colonization, inflammatory response and skin reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult (18 years of age or older) patient eligible for a bone anchored hearing system\n\nExclusion Criteria:\n\n* Inability or unwillingness to participate in follow-up\n* Skin thickness of \\> 10 mm\n* Diseases known to compromise bone quality\n* Irradiated in the implant area'}, 'identificationModule': {'nctId': 'NCT02304692', 'briefTitle': 'Clinical Survey of Different Abutment Topologies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticon Medical'}, 'officialTitle': 'C49:Clinical Survey of Different Abutment Topologies Installed With a Minimally Invasive Surgery for Bone Anchored Hearing Systems', 'orgStudyIdInfo': {'id': 'C49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Oticon Medical Machined Abutment', 'description': 'A non surface modified abutment is used', 'interventionNames': ['Device: Bone anchored hearing aid']}, {'type': 'EXPERIMENTAL', 'label': 'Oticon Medical Modified Abutment', 'description': 'A surface modified abutment is used', 'interventionNames': ['Device: Bone anchored hearing aid']}], 'interventions': [{'name': 'Bone anchored hearing aid', 'type': 'DEVICE', 'otherNames': ['BAHS', 'BAHA'], 'armGroupLabels': ['Oticon Medical Machined Abutment', 'Oticon Medical Modified Abutment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Otorhinolaryngology, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Sofia Jonhede', 'role': 'STUDY_CHAIR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticon Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}