New York, NY, May 17, 2017 (Newswire.com) - Dr. Nina Naidu, a board-certified plastic surgeon in New York City, is recruiting patients for a research study titled, “A Study on the Safety and Effectiveness of the Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture Baker Grade III.”
Capsular contracture is scar tissue that can form in the breasts of women who have undergone breast augmentation surgery for cosmetic or reconstructive reasons. Sometimes, this tissue can become firm, painful, and even distort the appearance of the breast. Traditionally, this scar tissue has been treated with surgery.
This study is being performed to evaluate the safety and effectiveness of a non-invasive device to treat capsular contracture. The device, the Aspen™ Ultrasound System, is an ultrasound machine which may soften breast implant capsules when used in conjunction with home exercises and special compression dressings. This machine is not yet FDA-approved in the United States for this use, although an Investigational Device Exemption (IDE) has been granted for its use in a clinical study.
Stage I of the study will evaluate and treat 10 women who have received saline breast implants placed into the subglandular (under the breast tissue) space for cosmetic enhancement of the breasts, and who have been diagnosed with Baker Grade III capsular contracture of the breast, which is associated with firmness and distortion of the breast. Stage II of the study will evaluate an additional 50 women who have received silicone or saline breast implants placed into the subglandular (under the breast tissue) or submuscular (under the muscle) space for cosmetic enhancement of the breasts, and who have been diagnosed with Baker Grade III capsular contracture.
Study subjects will be treated with the ultrasound device twice per week for five weeks. At each treatment visit, the affected breast(s) will also be manually massaged and compression dressings will be applied. Follow-up visits will be performed at 6 weeks, 3 months, 6 months, and one year following the last treatment. Each visit will last approximately 30 minutes, and the breasts will be examined and photographed at each visit. Subjects will be asked to complete a questionnaire both prior to treatment and at the final visit to assess their satisfaction with the results of the treatment and rehabilitation protocol. The data compiled from the study will be studied to determine if there are any safety issues with the device or the treatment, and if the protocol was effective in reducing the degree of contracture of the breast.
At this time as part of Stage I of the study, Dr. Naidu is recruiting potential study subjects aged 22 years or older, in good health, and who have a history of Grade III capsular contracture, which occurred following the placement of saline breast implants over the muscle for cosmetic reasons. Study subjects will not be charged for any of the treatments or visits.
For further information regarding the study or to schedule a visit to determine if you are eligible for inclusion, please contact the office of the investigator, Dr. Nina Naidu, at 212-452-1230.
This study has been approved by the Food and Drug Administration (Protocol #G160087) and the Institutional Review Board at Northwell Health System (protocol #16-791).
Nina S. Naidu, MD FACS
Plastic & Reconstructive Surgery
Location: 1021 Park Avenue, New York, NY 10028
Source: Dr. Nina Naidu