Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast
NCT ID: NCT04906811
Last Updated: 2024-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
17 participants
INTERVENTIONAL
2021-05-20
2024-02-12
Brief Summary
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Detailed Description
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Patients will be followed on post-procedure months 3, 6, and 12. Fat graft retention will be evaluated by photographic assessment by blinded reviewers, and 3D imaging. Patient satisfaction will be measured using the Breast-Q - Augmentation survey.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fat grafting with the AuraGen 1-2-3 with AuraClens System
Patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. Lipoaspirate processed with the AuraGen 1-2-3 with AuraClens system.
AuraGen 1-2-3 with AuraClens system (BK190433)
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system
Fat grafting with the Revolve System
Patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. Lipoaspirate processed with the Revolve System.
Revolve System (K120902)
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System
Interventions
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AuraGen 1-2-3 with AuraClens system (BK190433)
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system
Revolve System (K120902)
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) 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 400 and 1400 cc
* Anticipated fat injection volume 150-350 cc per breast
* Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in their diet or lifestyle during the study.
Exclusion Criteria
* Patients who smoke or use nicotine products.
* Patients with bleeding disorders or currently taking anticoagulants.
* Patients with a history of trauma or surgery to the treatment area.
* Patients with a history of breast cancer.
* Active, chronic, or recurrent infection.
* Compromised immune system (e.g. diabetes).
* Hypersensitivity to analgesic agents.
* Co-morbid conditions that could limit their 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 contraindicate the patient's participation.
* Patients who do not wish to have the study area (breast) photographed
NOTE Please note that there is no remuneration for participation in this study.
18 Years
65 Years
FEMALE
Yes
Sponsors
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AuraGen Aesthetics LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel A Del Vecchio, MD
Role: PRINCIPAL_INVESTIGATOR
Back Bay Plastic Surgery
Locations
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Back Bay Plastic Surgery
Boston, Massachusetts, United States
Countries
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Other Identifiers
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AUGCS001
Identifier Type: -
Identifier Source: org_study_id
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