Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting (NCT00466765) | Clinical Trial Compass
CompletedNot Applicable
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
United States589 participantsStarted 2010-01
Plain-language summary
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro grafting breast augmentation and reconstruction procedures.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Female volunteers between the ages of 18 and 80 years of age and weighing between 100- 275 lbs may be enrolled in the study. Ages 16 to 18 with developmental deformities may be enrolled with parental consent.
* Post implant removal with subcutaneous defect
* Post lumpectomy patients with or without radiation therapy with asymmetrical defect
* Post mastectomy with or without radiation therapy
* Post flap reconstruction with asymmetry or contour defect
* Primary breast augmentation
* Primary Post-mastectomy breast reconstruction
* Breast asymmetry
* Other congenital malformation of the breast such as constricted breasts, tubular breast, tuberous breasts, pectus associated deformities and Poland's Syndrome
Exclusion Criteria:
The following volunteers must be excluded from the study:
* A volunteer who has a positive pregnancy test
* A volunteer who has a pacemaker or aneurysm clips
* A volunteer who has had a cardiac stent placed within the last two months
* A volunteer who is claustrophobic
* A volunteer with a known, current substance abuse
* A volunteer with a history of silicone allergy
* A volunteer with a history of Gadolinium allergy (if MRI performed)
* A volunteer with a history of Lidocaine allergy
* A volunteer with a bleeding diathesis
* Untreated breast cancer
* A volunteer who smokes cigarettes or who has a history of smoking within the past three (3) months.
* Medical Conditions including Sever Hypertension, Renal disease, steroid dependant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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Digital photographic interpretation by Board Certified Plastic Surgeon or Radiologist.