Breast Fat Grafting Retention
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAuraGen 1-2-3 with AuraClens
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.
Sponsors
Tiger Biosciences, LLC.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Augmentation Subjects Inclusion Criteria: * Female patients \> 22 years and \< 65 years of age. * Patients with a BMI \< 35. * Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits. * Patients must be non-smokers. * Patients with available/adequate harvest sites for fat grafting. * Anticipated harvested fat volume between 200 and 700 cc. * Anticipated fat injection volume between 50 and 350 cc per breast. * Anticipated breast implant volume between 200 and 550 cc. * Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.
Exclusion criteria
* Skin rash in the treatment area. * Patients who smoke or use nicotine products. * Patients with bleeding disorders or currently taking anticoagulants. * Patients with history of trauma or surgery to the treatment area. * Patients with history of breast cancer. * Active, chronic, or recurrent infection. * Compromised immune system. * Hypersensitivity to analgesic agents. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements. * Untreated drug and/or alcohol abuse. * Pregnant or breastfeeding. * Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation. * Patients who do not wish to have the study area (breast) photographed. Reconstruction Subjects Inclusion Criteria: * Female patients \> 18 years and \< 65 years of age. * Patients with a BMI \< 35. * 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. * Patient is at least 1 year post-completion of chemotherapy. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits. * Patients must be non-smokers. * Patients with available/adequate harvest sites for fat grafting. * Anticipated harvested fat volume between 200 and 700 cc. * Anticipated fat injection volume between 50 nd 350cc per breast. * Anticipated breast implant volume (if applicable) between 200 and 550 cc. * Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat Grafting Volume Retention | 1 Year | Fat grafting volume retention from procedure to 12-months. |
| Patient Satisfaction | 1 Year | Confidence/Satisfaction |
Countries
United States
Contacts
STUDY_DIRECTORSara Saul, PhD
Tiger Biosciences, LLC.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.9 years |
| BMI | 26.4 kg/m2 STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 20 Participants |
| Race/Ethnicity, Customized Mixed | 4 Participants |
| Race/Ethnicity, Customized White | 159 Participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 105 |
| other Total, other adverse events | 2 / 85 | 0 / 105 |
| serious Total, serious adverse events | 0 / 85 | 0 / 105 |
Outcome results
None listed