Clinical Trial: Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:

Protocol:

Objectives: Two stages are proposed for this study. In Stage I, the objective is to demonstrate the safety of the Aspen System™ and Aspen Rehabilitation Technique in the treatment of Baker Grade III capsular contracture of the breast following subglandular placement of saline implants for cosmetic breast augmentation. The endpoint will be the determination of safety as defined by no adverse events, including implant rupture. Following review of interim data and approval by the FDA, Stage II will commence. In Stage II, the objective will be to demonstrate safety and efficacy of the Aspen System™ and Aspen Rehabilitation Technique in the treatment of Baker Grade III capsular contracture of the breast following subglandular or submuscular placement of saline or silicone implants for cosmetic breast augmentation. The endpoint will be the documentation of efficacy as demonstrated by the reduction of at least one Baker Grade following treatment with the Aspen™ System and Aspen Rehabilitation Technique.

Description: This is a prospective, non-randomized trial.

Conduct: The trial will be conducted as follows:

Study Subjects: Patients will be recruited from the investigator's private practice and the local community. In stage I, 10 women aged 22 years or older who have received saline breast implants for subglandular breast augmentation, and who subsequently developed Baker Grade III capsular contracture, will be invited to participate. Upon completion of the first stage of this study, the data will be submitted to the FDA for review. The second stage of the study will not commence until approval has been obtained by the FDA. At this time, for the second stage of the study, the study group will be expanded
Sponsor: Nina S. Naidu, MD

Current Primary Outcome:

• 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 [ Time Frame: 12 months ]
  The determination of safety as defined by no adverse events, including implant rupture, skin burns,
• 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 [ Time Frame: 12 months ]
  The documentation of efficacy as demonstrated by the reduction of at least one Baker Grade following treatment.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Naidu, Nina S., M.D.

Dates:
Date Received: July 19, 2016
Date Started: April 7, 2017
Date Completion: September 1, 2018
Last Updated: April 18, 2017
Last Verified: April 2017