Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-01-03 @ 6:54 PM
Study NCT ID:
NCT03502512
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2018-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat graft retention rate', 'timeFrame': 'At 1 year', 'description': 'Rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of the REVOLVE and PureGraft tissue processing techniques.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mammoplasty Patient']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.\n\nSECONDARY OBJECTIVES:\n\nI. To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.\n\nII. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.\n\nIII. To measure patient reported outcomes (PRO, BREAST-Questionnaire \\[Q\\], Body Image Survey).\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients undergo reconstructive surgery with REVOLVE technique.\n\nARM II: Patients undergo reconstructive surgery with PureGraft technique.\n\nAfter completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous breast surgery, either mastectomy or partial mastectomy\n* Patients with available harvest sites for fat grafting\n* Patients with body mass index (BMI) \\> 20\n* Anticipated harvested fat volume \\> 100 cc\n* Patients are willing and able to give consent\n\nExclusion Criteria:\n\n* Patients with active cancer, including primary cancer, recurrent cancer and locally or distantly metastatic cancer\n* Patients who are unable to provide consent\n* Patients who are suspected or known to be pregnant'}, 'identificationModule': {'nctId': 'NCT03502512', 'briefTitle': 'REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Randomized, Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction', 'orgStudyIdInfo': {'id': '2016-0463'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00944', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2016-0463', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (REVOLVE technique)', 'description': 'Patients undergo reconstructive surgery with REVOLVE technique.', 'interventionNames': ['Other: Questionnaire Administration', 'Procedure: Reconstructive Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (PureGraft technique)', 'description': 'Patients undergo reconstructive surgery with PureGraft technique.', 'interventionNames': ['Other: Questionnaire Administration', 'Procedure: Reconstructive Surgery']}], 'interventions': [{'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (REVOLVE technique)', 'Arm II (PureGraft technique)']}, {'name': 'Reconstructive Surgery', 'type': 'PROCEDURE', 'otherNames': ['Reconstruction'], 'description': 'Undergo reconstructive surgery with REVOLVE technique', 'armGroupLabels': ['Arm I (REVOLVE technique)']}, {'name': 'Reconstructive Surgery', 'type': 'PROCEDURE', 'otherNames': ['Reconstruction'], 'description': 'Undergo reconstructive surgery with PureGraft technique', 'armGroupLabels': ['Arm II (PureGraft technique)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Gregory Reece, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}