Stopped: adverse event
Purpose: The purpose of this investigation is to test the safety and effectiveness of the Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic treatment of capsular contracture of the breast in conjunction with the Aspen Rehabilitation Technique. The hypothesis of the proposed study is that external ultrasound with the Aspen System™ device in conjunction with the Aspen Rehabilitation Technique is safe and effective in the reduction by at least one level of Baker Grade III capsular contracture in cosmetic breast augmentation patients, maintained at one year from the final treatment. Potential benefits of the study to subjects include improvement in the grade of capsular contracture of the breast without surgical treatment. The investigation is planned to last 12 months.
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Safety (defined by no adverse events, including implant rupture, skin burns) of the Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture Baker Grade III
Timeframe: 12 months
Efficacy (reduction of at least one Baker Grade following treatment) of the Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture Baker Grade III
Timeframe: 12 months