Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture
Stopped early · Not applicable
Conditions studied: Capsular Contracture of Breast, Grade III
In brief
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.
Key facts
- Study ID
- NCT02840084
- Run by
- Nina Naidu
- People needed
- 10
- Starts
- 2019-09-15
- Expected to finish
- 2021-06-10
- Last updated by the study team
- 2021-06-15
Who can join
Age: 22 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Nina S. Naidu, MD PC — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.