Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-10 @ 9:24 PM
Study NCT ID:
NCT03723161
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2018-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006314', 'term': 'Hearing Loss, Conductive'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stability 12 months', 'timeFrame': '12 months post surgery', 'description': 'The development of implant stability during the first 12 months after implantation; as measured by difference in mean of (Implant Stability Quotient) ISQ low 12 months compared to surgery.'}], 'secondaryOutcomes': [{'measure': 'Stability 24 months', 'timeFrame': '24 months post surgery', 'description': 'Difference in mean of ISQ low at 24 months compared to surgery'}, {'measure': 'Implant survival rate', 'timeFrame': '24 months post surgery', 'description': 'Implant survival rate in percent compared to litterature'}, {'measure': 'Performance audibility PTA4', 'timeFrame': '1 month post surgery', 'description': 'The difference between abutment-aided and softband-aided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) in preoperative condition and at fitting.'}, {'measure': 'Performance audibility', 'timeFrame': '1 month post surgery', 'description': 'Difference between abutment-aided and softband-aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz) in preoperative condition and at fitting'}, {'measure': 'Performance speech intelligibility', 'timeFrame': '1 month post surgery', 'description': 'Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting.'}, {'measure': 'Functional assessment', 'timeFrame': '12 months, 24 months', 'description': 'Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH)'}, {'measure': 'Skin conditions Holger', 'timeFrame': '7-10 days,12 months, 24 months post surgery', 'description': 'Skin assessment as assessed with maximum Holgers score per patient. Maximum score 4. 0= no adverse skin reaction, 4=maximum adverse skin reaction.'}, {'measure': 'Skin conditions IPS evaluation', 'timeFrame': '7-10 days,12 months, 24 months post surgery', 'description': 'Skin condition as assessed by (Inflammation, Pain, Skin height/numbness (IPS) score. I scale randing from 0-4, Pain scale ranging from 0-2, Height scale ranging from 0-2. Total score 8, 0=no adverse skin reaction, 8=maximum adverse skin reaction'}, {'measure': 'Sustainability of audibility PTA4 performance', 'timeFrame': '1 month, 12 months, 24 months post surgey', 'description': 'Difference between abutment aided sound field PTA 4 over time'}, {'measure': 'Sustainability of audibility performance', 'timeFrame': '1 month, 12 months, 24 months post surgey', 'description': 'Difference between abutment aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz over time'}, {'measure': 'Sustainability of speech intelligibility performance', 'timeFrame': '1 month, 12 months, 24 months post surgey', 'description': 'Difference between abutment aided speech intelligibility over time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Conductive Hearing Loss', 'Atresia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '30 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients eligible for a bone anchored solution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have decided to undergo a Bone Anchored Hearing Surgery\n* Diagnosed with atresia\n* Signed informed consent\n* Patients between 2,5 - 18 years of age\n* Patients eligible for one stage surgery\n\nExclusion Criteria:\n\n* Not fluent in Swedish or English; subject and/or legal guardian\n* Unwillingness to participate in follow up visits'}, 'identificationModule': {'nctId': 'NCT03723161', 'briefTitle': 'Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticon Medical'}, 'officialTitle': 'Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population', 'orgStudyIdInfo': {'id': 'C64'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical', 'interventionNames': ['Device: Bone Achored Hearing surgery']}], 'interventions': [{'name': 'Bone Achored Hearing surgery', 'type': 'DEVICE', 'description': 'This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticon Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}