Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 or submuscular placement of saline or silicone 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 or silicone breast implants for subglandular or submuscular 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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10028
- Nina S. Naidu, MD PC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Two transducers per breast are applied. There will be 10 30 minute sessions, with 2 sessions per week for five weeks. The transducers will be placed on the medial and lateral positions of the affected breast, and then rotated to the superior and inferior aspects, and finally directly over the nipple-areolar complex. Following treatment, the affected breast will be massaged and bandaged per the Aspen Rehabilitation protocol, and the patient will be provided with home exercises as part of the Aspen Rehabilitation Technique. The treated breast(s) will be examined both prior to and immediately following each treatment session. To evaluate safety, any adverse events such as swelling, redness, or pain will be assessed. To determine efficacy, any change in the Baker Grade level will be assessed by physical examination. The breasts will be photographed prior to treatment at each visit to assist in evaluation of any visible change in the breasts. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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,
|
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
Time Frame: 12 months
|
The documentation of efficacy as demonstrated by the reduction of at least one Baker Grade following treatment.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nina Naidu, MD, Surgeon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G160087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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