Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): adverse event
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Capsular Contracture of Breast, Grade III | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspen(TM) Ultrasound System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Patients
- description
- 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.
- interventionNames
- Device: Aspen(TM) Ultrasound System
Primary outcomes (2)
- measure
- 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
- timeFrame
- 12 months
- description
- The determination of safety as defined by no adverse events, including implant rupture, skin burns,
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available