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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Breast Reconstruction
  • Age: Between 22 - 65 Years
  • Gender: Female
  • Other Inclusion Criteria:
      Augmentation Inclusion Criteria:
    1. Female patients > 22 years and < 65 years of age.
    2. Patients with a BMI < 35.
    3. Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant.
    4. Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
    5. Patients must be non-smokers.
    6. Patients with available/adequate harvest sites for fat grafting.
    7. Anticipated harvested fat volume between 200 and 700 cc.
    8. Anticipated fat injection volume 50-350 cc per breast.
    9. Anticipated breast implant (if used) volume between 200 and 550 cc.
      Reconstruction Inclusion Criteria:
    1. Female patients > 18 years and < 65 years of age.
    2. Patients with a BMI < 35.
    3. 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.
    4. Patient is at least 1year post-completion of chemotherapy.
    5. Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
    6. Patients must be non-smokers.
    7. Patients with available/adequate harvest sites for fat grafting.
    8. Anticipated harvested fat volume between 200 and 700 cc.
    9. Anticipated fat injection volume 50-350 cc per breast.
    10. Anticipated breast implant (if used) volume between 200 and 700 cc.
    11. Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study.

You may not be eligible for this study if the following are true:

    1. Augmentation Exclusion Criteria:
    2. Skin rash in the treatment area.
    3. Patients who smoke or use nicotine products.
    4. Patients with bleeding disorders or currently taking anticoagulants.
    5. Patients with history of trauma or surgery to the treatment area.
    6. Patients with history of breast cancer.
    7. Active, chronic, or recurrent infection.
    8. Compromised immune system.
    9. Hypersensitivity to analgesic agents.
    10. Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
    11. Untreated drug and/or alcohol abuse.
    12. Pregnant or breastfeeding.
    13. Any issue that, at the discretion of the Investigator, would contra-indicate the patient’s participation.
    14. Patients who do not wish to have the study area (breast) photographed.
      Reconstruction Exclusion Criteria
    1. Patients who have undergone radiotherapy treatments to the breast.
    2. Skin rash in the treatment area.
    3. Patients who smoke or use nicotine products.
    4. Patients with bleeding disorders or currently taking anticoagulants.
    5. Patients undergoing active treatment for breast cancer.
    6. Active, chronic, or recurrent infection.
    7. Compromised immune system.
    8. Hypersensitivity to analgesic agents.
    9. Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
    10. Untreated drug and/or alcohol abuse.
    11. Pregnant or breastfeeding.
    12. Any issue that, at the discretion of the Investigator, would contra-indicate the patient’s participation.
    13. Patients who do not wish to have the study area (breast) photographed.



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