Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture
Capsular Contracture of Breast, Grade III
About this trial
This is an interventional treatment trial for Capsular Contracture of Breast, Grade III focused on measuring breast implant capsular contracture
Eligibility Criteria
Inclusion Criteria:
Stage I:
- Age 22 years or greater,
- Cosmetic breast augmentation,
- Baker Grade III capsular contracture, subglandular implant position, saline implants.
Stage II:
- Age 22 years or greater,
- Cosmetic breast augmentation,
- Baker Grade III capsular contracture, subglandular or submuscular implant position, saline or silicone gel implants.
Exclusion Criteria:
- History of breast cancer,
- prior radiation therapy to chest wall,
- ruptured breast implant,
- calcification of capsules seen on any imaging study,
- implants > 15 years old,
- prior treatment for capsular contracture in past 12 months (open capsulectomy, open capsulotomy, implant exchange, implant plane change, placement of acellular dermal matrix, explantation, closed capsulotomy, or oral medication),
- metal implants,
- pacemakers,
- defibrillators,
- history of epilepsy,
- history of bleeding, and undiagnosed pain syndromes,
- pregnancy,
- currently lactating,
- acute and sub-acute thrombosis and thrombophlebitis,
- potentially malignant tumors,
- benign tumors,
- malignancy,
- third-degree musculotendinous lesions,
- multiple sclerosis,
- osteomyelitis,
- cardiac arrhythmias,
- acute sepsis of tissue or bone,
- arteriosclerosis,
- hemophilia, and
- sensory nerve damage.
Sites / Locations
- Nina S. Naidu, MD PC
Arms of the Study
Arm 1
Experimental
Treatment Patients
In stage I, 10 women aged 22 years or older who have received silicone or saline breast implants for subglandular or submuscular breast augmentation, and who subsequently developed Baker Grade III capsular contracture, will be invited to participate. In Stage II, the study group will be expanded to include an additional 50 patients who have received saline or silicone gel implants, placed in either the subglandular or submuscular position, with Grade III capsular contracture of the breast. The intervention will be treatment with the Aspen(TM) Ultrasound System.