Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT02438618
Status:
COMPLETED
Last Update Posted:
2019-09-03
First Post:
2015-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skin position (analysed descriptively using photographs and computer software)', 'timeFrame': '3 months post surgery', 'description': 'Only at main center'}, {'measure': 'Dynamic skin motion (analysed descriptively using photographs and computer software)', 'timeFrame': '3 months post surgery', 'description': 'Only at main center'}, {'measure': 'Quality of life related questionnaires', 'timeFrame': '24 months post surgery'}, {'measure': 'Correlation between cytokines and Holgers index', 'timeFrame': '24 months post surgery'}, {'measure': 'Correlation IS-pro profile and Holgers index', 'timeFrame': '24 months post surgery'}, {'measure': 'Development of a peri-implant dermatitis scale and compare it to the Holgers Index', 'timeFrame': '24 months post surgery'}], 'primaryOutcomes': [{'measure': 'Incidence of inflammation (Holgers index ≥ 2)', 'timeFrame': '3 months post surgery'}], 'secondaryOutcomes': [{'measure': 'Presence of dehiscence after surgery (Noted in a binary fashion (present/not present))', 'timeFrame': '3 months post surgery'}, {'measure': 'Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)', 'timeFrame': '3 months post surgery'}, {'measure': 'Loss of sensibility (Measured in mm outwards from the abutment)', 'timeFrame': '3 months post surgery'}, {'measure': 'Soft tissue overgrowth (mm)', 'timeFrame': '3 months post surgery'}, {'measure': 'Extrusion rate (number of implants lost)', 'timeFrame': '3 months post surgery'}, {'measure': 'Implant stability quotient (ISQ) measurements (ISQ units 1-100)', 'timeFrame': '3 months post surgery'}, {'measure': 'Surgical time (minutes)', 'timeFrame': '3 months post surgery'}, {'measure': 'Wound healing time (time to reach healed)', 'timeFrame': '3 months post surgery'}, {'measure': 'Holgers index ≥ 2 at any time point', 'timeFrame': '24 months post surgery'}, {'measure': 'Presence of dehiscence after surgery (present/not present)', 'timeFrame': '24 months post surgery'}, {'measure': 'Visual Analogue Scale (VAS) pain scale > 6 (Noted on a scale from 0 - 10)', 'timeFrame': '24 months post surgery'}, {'measure': 'Loss of sensibility (Measured in mm outwards from the abutment)', 'timeFrame': '24 months post surgery'}, {'measure': 'Soft tissue overgrowth (mm)', 'timeFrame': '24 months post surgery'}, {'measure': 'Extrusion rate (number of implants lost)', 'timeFrame': '24 months post surgery'}, {'measure': 'Implant stability quotient (ISQ) measurements (ISQ units 1-100)', 'timeFrame': '24 months post surgery', 'description': 'Measured in ISQ units (1-100)'}, {'measure': 'Cosmetic result (10 point scale)', 'timeFrame': '24 months post surgery', 'description': 'Scored using a 10-point scale and are compared to the healthy, normal contralateral situation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Conductive Hearing Loss', 'Unilateral Partial Deafness', 'Mixed Conductive-sensorineural Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '37400140', 'type': 'DERIVED', 'citation': 'Strijbos RM, Straatman LV, Stegeman I, Holmberg M, Johansson ML, Stokroos RJ. Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation. Otol Neurotol. 2023 Aug 1;44(7):709-717. doi: 10.1097/MAO.0000000000003939. Epub 2023 Jun 29.'}, {'pmid': '33716934', 'type': 'DERIVED', 'citation': 'Strijbos RM, Straatman LV, Calon TGA, Johansson ML, de Bruijn AJG, van den Berge H, Wagenaar M, Eichhorn E, Janssen M, Jonhede S, van Tongeren J, Holmberg M, Stokroos R. Long-Term Outcomes of the Minimally Invasive Ponto Surgery vs. Linear Incision Technique With Soft Tissue Preservation for Installation of Percutaneous Bone Conduction Devices. Front Neurol. 2021 Feb 24;12:632987. doi: 10.3389/fneur.2021.632987. eCollection 2021.'}, {'pmid': '27829464', 'type': 'DERIVED', 'citation': 'Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ. Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial. Trials. 2016 Nov 9;17(1):540. doi: 10.1186/s13063-016-1662-0.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to make a comparison between two surgical techniques used when implanting a Ponto bone anchored hearing system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, i.e. ≥ 18 years of age\n* Eligible for the Ponto system\n\nExclusion Criteria:\n\n* Known history of immunosuppressive disease\n* Use of systemic immunosuppressive medication\n* Receiving bilateral bone anchored hearing system\n* Relevant dermatological diseases as judged by the investigator\n* Not being able to finish the study, for example because of failure to complete the questionnaires\n* Participating in another study with medical aids or medication\n* When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.'}, 'identificationModule': {'nctId': 'NCT02438618', 'acronym': 'C50', 'briefTitle': 'Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticon Medical'}, 'officialTitle': 'Minimally Invasive Surgery for Ponto Bone Anchored Hearing Implants', 'orgStudyIdInfo': {'id': 'C50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally invasive punch technique', 'description': 'New surgical technique for Ponto bone anchored hearing implants', 'interventionNames': ['Procedure: Surgery for Ponto bone anchored hearing aids']}, {'type': 'OTHER', 'label': 'Hultcrantz technique', 'description': 'Standard surgical technique for bone anchored hearing implants', 'interventionNames': ['Procedure: Surgery for Ponto bone anchored hearing aids']}], 'interventions': [{'name': 'Surgery for Ponto bone anchored hearing aids', 'type': 'PROCEDURE', 'armGroupLabels': ['Hultcrantz technique', 'Minimally invasive punch technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Robert Stokroos, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Centre (MUMC+)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticon Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}