Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT04310202
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2020-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety outcome', 'timeFrame': '12 months after surgery', 'description': 'Occurrence and severity of adverse events related to the investigational device and corresponding procedures'}], 'primaryOutcomes': [{'measure': 'Implant/abutment complex capability to provide a reliable Anchorage for a sound processor', 'timeFrame': '3 months after implant surgery', 'description': 'The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable. without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.'}], 'secondaryOutcomes': [{'measure': 'Implant/abutment complex capability to provide reliable anchorage for sound processor', 'timeFrame': '12 months after implant surgery', 'description': 'The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.'}, {'measure': 'Implant survival', 'timeFrame': '12 months after implant surgery', 'description': 'Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place \\[Yes/No\\]'}, {'measure': 'Implant stability', 'timeFrame': '12 months after implant surgery', 'description': 'Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable \\[Yes/No\\]'}, {'measure': 'Holgers score ratings', 'timeFrame': '12 months after implant surgery', 'description': 'Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator'}, {'measure': 'IPS (Inflammation, Pain, Skin height) scores', 'timeFrame': '12 months after implant surgery', 'description': 'Distribution of IPS (Inflammation \\[total score 0-4\\], Pain \\[score 0-2\\], Skin height \\[score 0-2\\]) scores assigned by investigator. The IPS score is presented as \\[Ix Px Sx\\] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome'}, {'measure': 'Patient-perceived presence of pain around implant/abutment', 'timeFrame': '12 months after implant surgery', 'description': 'Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject'}, {'measure': 'Patient-perceived magnitude of pain around implant/abutment', 'timeFrame': '12 months after implant surgery', 'description': 'Assessment of magnitude of patient-perceived pain using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome'}, {'measure': 'Patient-perceived presence of numbness around implant/abutment', 'timeFrame': '12 months after implant surgery', 'description': 'Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject'}, {'measure': 'Patient-perceived magnitude of numbness around implant/abutment', 'timeFrame': '12 months after implant surgery', 'description': 'Assessment of magnitude of patient-perceived numbness using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome'}, {'measure': 'Skin/soft tissue overgrowth', 'timeFrame': '12 months after implant surgery', 'description': 'Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question'}, {'measure': 'Duration of surgery', 'timeFrame': 'At implant surgery', 'description': 'Length of surgery measured in minutes'}, {'measure': 'Wound dehiscence', 'timeFrame': '12 months after implant surgery', 'description': 'Prevalence of wound dehiscence measured as millimeters of dehiscence'}, {'measure': 'Wound healing time', 'timeFrame': '12 months after implant surgery', 'description': 'Average healing time \\[days\\] from surgery when the wound is considered healed'}, {'measure': 'Implant/abutment usage', 'timeFrame': '12 months after implant surgery', 'description': 'Mean hours of use of a sound processor on the implant/abutment'}, {'measure': 'Subjective benefit after implant surgery', 'timeFrame': 'At screening visit (visit before surgery)', 'description': 'Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome'}, {'measure': 'Subjective benefit after implant surgery', 'timeFrame': '6 months after implant surgery', 'description': 'Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome'}, {'measure': 'Subjective benefit after implant surgery', 'timeFrame': '3 months after implant surgery', 'description': 'Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where \\[-100\\] means maximum adverse effect, \\[0\\] means no effect, and \\[+100\\] means maximum positive effect'}, {'measure': 'Subjective benefit after implant surgery', 'timeFrame': '12 months after implant surgery', 'description': 'Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where \\[-100\\] means maximum adverse effect, \\[0\\] means no effect, and \\[+100\\] means maximum positive effect'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.\n\nThe purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.', 'detailedDescription': 'This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.\n\nThe purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to participating clinics who meet clinical indications for surgical intervention with a bone anchored hearing system', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines\n* Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected\n\nExclusion Criteria:\n\n* Patients undergoing re-implantation\n* Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.\n* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus\n* Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator\n* Any other known condition that the investigator determines could interfere with compliance or study assessments"}, 'identificationModule': {'nctId': 'NCT04310202', 'briefTitle': 'Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticon Medical'}, 'officialTitle': 'A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System', 'orgStudyIdInfo': {'id': 'Doc-00066211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single-arm', 'description': 'In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery.', 'interventionNames': ['Other: Abbreviated Profile of Hearing Aid Benefit (APHAB)', 'Other: Glasgow Benefit Inventory (GBI)', 'Other: Additional follow-up visits after surgery']}], 'interventions': [{'name': 'Abbreviated Profile of Hearing Aid Benefit (APHAB)', 'type': 'OTHER', 'description': 'An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions.', 'armGroupLabels': ['Single-arm']}, {'name': 'Glasgow Benefit Inventory (GBI)', 'type': 'OTHER', 'description': 'An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions.', 'armGroupLabels': ['Single-arm']}, {'name': 'Additional follow-up visits after surgery', 'type': 'OTHER', 'description': 'There are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '20014', 'city': 'San Sebastián', 'state': 'Gipuzkoa', 'country': 'Spain', 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'B15 2WB', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Rupan Banga, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Birmingham NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticon Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}