Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 4/5/2019 |
| Start Date: | May 15, 2019 |
| End Date: | September 1, 2020 |
| Contact: | Nina Naidu, MD |
| Email: | drnaidu@naiduplasticsurgery.com |
| Phone: | 212-452-1230 |
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
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.
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.
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.
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.
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.
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