Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 2:50 AM
Study NCT ID:
NCT03194269
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2017-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2017-06-07', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score', 'timeFrame': 'Baseline to month 3', 'description': 'EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation', 'timeFrame': 'Baseline to Month 12', 'description': 'EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation', 'timeFrame': 'Baseline to Month 24', 'description': 'EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)'}, {'measure': 'Percentage of patients that require re-operation at any moment', 'timeFrame': '24 months', 'description': 'Percentage of patients that require re-operation at any moment during the investigational period'}, {'measure': 'Percentage of patients with recurrence of ear prominence', 'timeFrame': '24 months', 'description': 'Percentage of patients with recurrence of ear prominence at any moment during the investigational period'}, {'measure': 'Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years', 'timeFrame': 'Baseline to Month 3', 'description': 'The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being'}, {'measure': 'Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years', 'timeFrame': 'Baseline to Month 12', 'description': 'The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being'}, {'measure': 'Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years', 'timeFrame': 'Baseline to Month 24', 'description': 'The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being'}, {'measure': 'Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old', 'timeFrame': 'Baseline to Month 3', 'description': 'The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being'}, {'measure': 'Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old', 'timeFrame': 'Baseline to Month 12', 'description': 'The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being'}, {'measure': 'Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old', 'timeFrame': 'Baseline to Month 24', 'description': 'The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being'}, {'measure': 'Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3', 'timeFrame': 'Baseline to Month 3', 'description': 'Helix to scalp distance with untreated ears compared to EARFOLD in'}, {'measure': 'Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'Helix to scalp distance with untreated ears compared to EARFOLD in'}, {'measure': 'Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24', 'timeFrame': 'Baseline to Month 24', 'description': 'Helix to scalp distance with untreated ears compared to EARFOLD in'}, {'measure': 'Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD', 'timeFrame': 'Month 3 to Month 12', 'description': 'Helix to scalp distance with EARFOLD inserted'}, {'measure': 'Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD', 'timeFrame': 'Month 3 to Month 24', 'description': 'Helix to scalp distance with EARFOLD inserted'}, {'measure': 'Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3', 'timeFrame': 'Baseline to Month 3', 'description': 'Helix to scalp distance with PREFOLD® in compared with EARFOLD in'}, {'measure': 'Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'Helix to scalp distance with PREFOLD® in compared with EARFOLD in'}, {'measure': 'Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24', 'timeFrame': 'Baseline to Month 24', 'description': 'Helix to scalp distance with PREFOLD® in compared with EARFOLD in'}, {'measure': 'Duration of EARFOLD® insertion procedure', 'timeFrame': 'Duration of surgery', 'description': 'From the first incision of the scalpel to the last application of the sterristrip over the wound, duration of surgery'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3', 'timeFrame': 'Baseline to Month 3', 'description': 'EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24', 'timeFrame': 'Baseline to Month 24', 'description': 'EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3', 'timeFrame': 'Baseline to Month 3', 'description': 'EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24', 'timeFrame': 'Baseline to Month 24', 'description': 'EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3', 'timeFrame': 'Baseline to Month 3', 'description': 'EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24', 'timeFrame': 'Baseline to Month 24', 'description': 'EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always)'}, {'measure': 'Return to normal activities questionnaire after EARFOLD® surgery at Month 3', 'timeFrame': 'Month 3', 'description': 'Return to normal activities questionnaire is on a 11-point scale ranging from 10=strongly agree to 0=strongly disagree'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prominent Ears']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=CMO-EAME-FAS-0469&Latitude=&Longitude=&LocationName=#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have ear prominence and/or have significant asymmetry\n\nExclusion Criteria:\n\n* Subjects planning to use EARFOLD® in conjunction with other procedures (e.g. cartilage scoring, conchal reduction or concho-mastoid sutures) for correction of prominent ears are excluded\n* Patients with impaired healing (e.g., current smokers, diabetic patients, patients with autoimmune disorders such as Ehlers-Danlos Syndrome or Scleroderma)\n* Patients with an active infection, local or systemic\n* Patients with known nickel or gold allergies.'}, 'identificationModule': {'nctId': 'NCT03194269', 'acronym': 'FOLD', 'briefTitle': 'Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'FOLD: Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears', 'orgStudyIdInfo': {'id': 'CMO-EAME-FAS-0469'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EARFOLD®', 'description': 'EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic', 'interventionNames': ['Device: EARFOLD®']}], 'interventions': [{'name': 'EARFOLD®', 'type': 'DEVICE', 'description': 'EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic', 'armGroupLabels': ['EARFOLD®']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE22 3NE', 'city': 'Derby', 'state': 'Derbyshire', 'country': 'United Kingdom', 'facility': 'University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'London, City of', 'country': 'United Kingdom', 'facility': 'The Royal Free London NHS Foundation Trust /ID# 233617', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'G1 1SS', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'La Belle Forme /ID# 233664', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'L1 9DS', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Sthetix /ID# 233668', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SP1 3SL', 'city': 'Salisbury', 'country': 'United Kingdom', 'facility': 'Medcentres Plus /ID# 233687', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'zip': 'WV6 0BW', 'city': 'Wolvehampton', 'country': 'United Kingdom', 'facility': 'AL Aesthetics /ID# 233672'}], 'overallOfficials': [{'name': 'ALLERGAN INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing, please refer to the link below', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}