Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT05258305
Status:
UNKNOWN
Last Update Posted:
2023-12-04
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a non-randomized open-label study with a patient population consisting of up to 200 subjects divided in 2 cohorts with 100 patients each: reconstruction and augmentation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat Grafting Volume Retention', 'timeFrame': '1 Year', 'description': 'Fat grafting volume retention change from baseline to 12-months.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '1 Year', 'description': 'Sientra Breast Satisfaction Questionnaire survey results at 1, 3, 6 and 12-months post-operatively compared to baseline, based on a rating scale between 1 ("Strongly Disagree") to 7 ("Strongly Agree").'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Fat Grafting Retention']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.', 'detailedDescription': 'Autologous fat transfer (AFT) is a medical procedure that includes aspirating adipose tissue from one part of the body, and washing, filtering and re-injecting the processed fat tissue into a different part of the body with the primary purpose of adding volume. The AuraGen1-2-3 with AuraClens Lipoaspirate Wash System is designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister. The study population will consist of up to 200 subjects in (2) cohorts: 100 subjects undergoing breast reconstruction and 100 subjects undergoing breast augmentation. All subjects will receive autologous lipoaspirate processed with the A123+ AuraClens and will be followed post-procedure at 1-, 3-, 6-, and 12-months. Fat graft retention will be evaluated with 3D imaging using the Canfield Vectra XT imaging system. Patient satisfaction will be measured between baseline and the post-procedure follow-up visits using a breast satisfaction questionnaire.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Augmentation Subjects\n\nInclusion Criteria:\n\n* Female patients \\> 22 years and \\< 65 years of age.\n* Patients with a BMI \\< 35.\n* Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant.\n* Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.\n* Patients must be non-smokers.\n* Patients with available/adequate harvest sites for fat grafting.\n* Anticipated harvested fat volume between 200 and 700 cc.\n* Anticipated fat injection volume between 50 and 350 cc per breast.\n* Anticipated breast implant volume between 200 and 550 cc.\n* Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.\n\nExclusion Criteria:\n\n* Skin rash in the treatment area.\n* Patients who smoke or use nicotine products.\n* Patients with bleeding disorders or currently taking anticoagulants.\n* Patients with history of trauma or surgery to the treatment area.\n* Patients with history of breast cancer.\n* Active, chronic, or recurrent infection.\n* Compromised immune system.\n* Hypersensitivity to analgesic agents.\n* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.\n* Untreated drug and/or alcohol abuse.\n* Pregnant or breastfeeding.\n* Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation.\n* Patients who do not wish to have the study area (breast) photographed.\n\nReconstruction Subjects\n\nInclusion Criteria:\n\n* Female patients \\> 18 years and \\< 65 years of age.\n* Patients with a BMI \\< 35.\n* Patients undergoing a fat grafting procedure to the breast in a second or third stage of a staged breast reconstruction, with or without a breast implant.\n* Patient is at least 1 year post-completion of chemotherapy.\n* Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.\n* Patients must be non-smokers.\n* Patients with available/adequate harvest sites for fat grafting.\n* Anticipated harvested fat volume between 200 and 700 cc.\n* Anticipated fat injection volume between 50 nd 350cc per breast.\n* Anticipated breast implant volume (if applicable) between 200 and 550 cc.\n* Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.\n\nExclusion Criteria:\n\n* Skin rash in the treatment area.\n* Patients who smoke or use nicotine products.\n* Patients with bleeding disorders or currently taking anticoagulants.\n* Patients undergoing active treatment for breast cancer.\n* Active, chronic, or recurrent infection.\n* Compromised immune system.\n* Hypersensitivity to analgesic agents.\n* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.\n* Untreated drug and/or alcohol abuse.\n* Pregnant or breastfeeding.\n* Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation.\n* Patients who do not wish to have the study area (breast) photographed."}, 'identificationModule': {'nctId': 'NCT05258305', 'acronym': 'AuraGen', 'briefTitle': 'AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tiger Biosciences, LLC.'}, 'officialTitle': 'Prospective Study on Fat Retention When Using the AuraGen 1-2-3™ With AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast', 'orgStudyIdInfo': {'id': 'AUG-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Augmentation', 'description': 'Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.', 'interventionNames': ['Device: AuraGen 1-2-3 with AuraClens']}, {'type': 'OTHER', 'label': 'Reconstruction', 'description': 'Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.', 'interventionNames': ['Device: AuraGen 1-2-3 with AuraClens']}], 'interventions': [{'name': 'AuraGen 1-2-3 with AuraClens', 'type': 'DEVICE', 'description': 'Autologous fat transfer (AFT) is a minimally invasive medical procedure that includes aspirating adipose tissue from one part of the body, and washing, filtering and re-injecting the processed fat tissue into a different part of the body with the primary purpose of adding volume. The AuraGen 1-2-3 with AuraClens is a lipoaspirate wash system designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister.', 'armGroupLabels': ['Augmentation', 'Reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tessler Plastic Surgery', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Aura Aesthetica, Inc.', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Miami / Miami Cancer Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46290', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Meridian Plastic Surgery', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '66223', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Ascentist Plastic Surgery', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40222', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Calo Aesthetics', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70002', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Dallas Plastic Surgery', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '07784', 'city': 'West Long Branch', 'state': 'New Jersey', 'country': 'United States', 'facility': 'V Plastic Surgery', 'geoPoint': {'lat': 40.29039, 'lon': -74.01764}}, {'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Plastic Surgery Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Luxurgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hunstad Kortesis Bharti Cosmetic Surgery', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Restora Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75082', 'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'facility': 'Regional Plastic Surgery', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}, {'zip': '75205', 'city': 'University Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Plastic Surgery', 'geoPoint': {'lat': 32.85013, 'lon': -96.80028}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Bellevue Plastic Surgery', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Denise Dajles, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tiger Biosciences, LLC.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tiger Biosciences, LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}