Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-02-06 @ 6:34 AM
Study NCT ID:
NCT02727595
Status:
UNKNOWN
Last Update Posted:
2016-04-04
First Post:
2016-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IMA Reduction', 'timeFrame': 'One year', 'description': 'The IMA angle is measured pre-op and post-op on x-ray images using internal software. The IMA at end of study should be less than 10 degrees or a reduction of more than 5 degrees.'}], 'secondaryOutcomes': [{'measure': 'American Orthopedic Foot and Ankle Society (AOFAS) Score', 'timeFrame': 'One year', 'description': 'General improvement as assessed by AOFAS Hallux Scale metatarsophalangeal interphalangeal scale score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hallux Valgus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate safety, tolerability and performance of the CyclaPlex implant, a button and suture type implant device and instruments for the correction of the first inter metatarsal angle in subjects suffering from Hallux Valgus deformity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight less than 100 kilos\n* IMA greater than 12 degrees\n* IMA less than 7 degrees\n\nExclusion Criteria:\n\n* Diabetics\n* Known osteoporosis\n* Known allergy or hypersensitivity to metals\n* Gout or any systemic inflammatory arthropathy'}, 'identificationModule': {'nctId': 'NCT02727595', 'briefTitle': 'Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': 'HYMC-19-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CyclaPlex Implant', 'description': 'Implant device for reduction of the inter metatarsal angle (IMA) without osteotomy.', 'interventionNames': ['Device: CyclaPlex Implant']}], 'interventions': [{'name': 'CyclaPlex Implant', 'type': 'DEVICE', 'description': 'Button and suture type implant that will be implanted between the first and second metatarsal', 'armGroupLabels': ['CyclaPlex Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Ori Hadash, MD', 'role': 'CONTACT', 'email': 'cafregel@gmail.com'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Rafi Herzog, BSc', 'role': 'CONTACT', 'email': 'rherzog@netvision.net.il'}], 'overallOfficials': [{'name': 'Ori Hadash, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cycla Orthopedics Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}