Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-02 @ 6:44 PM
Study NCT ID:
NCT01416233
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2011-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-09-10', 'releaseDate': '2019-08-05'}], 'estimatedResultsFirstSubmitDate': '2019-08-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2011-05-30', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique', 'timeFrame': '1-5 years', 'description': 'Autologous fat will be injected into the orbits of anophthalmic human subjects with secondary loss of orbital volume'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autologous', 'fat', 'orbit', 'atrophy', 'cannula'], 'conditions': ['Orbital Fat Atrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.newyorkfami.com', 'label': 'further information'}]}, 'descriptionModule': {'briefSummary': 'After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.', 'detailedDescription': 'To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis.\n\nTo date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. The study period has been extended to include MRIs at 2 and 5 years after injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting\n* standard sphere or integrated orbital implantation\n* phthisis bulbi are candidates\n\nExclusion Criteria:\n\n* class 3 or greater anesthesia risk\n* infection\n* inability to follow study protocol'}, 'identificationModule': {'nctId': 'NCT01416233', 'briefTitle': 'Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique', 'organization': {'class': 'INDIV', 'fullName': 'Fox, Donald Munro, M.D., P.C.'}, 'officialTitle': 'Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique', 'orgStudyIdInfo': {'id': '10.27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous fat grafting', 'description': 'There is one arm of this study. People with anophthalmic sockets and orbital atrophy are given a single session of autologous fat grafting by a closed cannula technique and are observed to measure, by MRI, the amount of fat retained at one year', 'interventionNames': ['Procedure: autologous fat grafting to the orbit']}], 'interventions': [{'name': 'autologous fat grafting to the orbit', 'type': 'PROCEDURE', 'description': 'subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit', 'armGroupLabels': ['autologous fat grafting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fox, Donald Munro, M.D., P.C.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fox, Donald Munro, M.D.', 'investigatorFullName': 'Donald M Fox, MD', 'investigatorAffiliation': 'Fox, Donald Munro, M.D., P.C.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-08-05', 'type': 'RELEASE'}, {'date': '2019-09-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Donald M Fox, MD, Fox, Donald Munro, M.D., Fox, Donald Munro, M.D., P.C.'}}}}