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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840084
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Nina S. Naidu, MD, Naidu, Nina S., M.D.

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.

Condition or disease Intervention/treatment Phase
Capsular Contracture of Breast, Grade III Device: Aspen(TM) Ultrasound System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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.
Device: 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.





Primary Outcome Measures :
  1. 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,

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840084


Contacts
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Contact: Nina Naidu, MD 212-452-1230 drnaidu@naiduplasticsurgery.com

Locations
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United States, New York
Nina S. Naidu, MD PC Recruiting
New York, New York, United States, 10028
Contact: Nina Naidu, MD         
Sponsors and Collaborators
Nina S. Naidu, MD
Investigators
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Principal Investigator: Nina Naidu, MD surgeon
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Responsible Party: Nina S. Naidu, MD, Plastic & Reconstructive Surgeon, Naidu, Nina S., M.D.
ClinicalTrials.gov Identifier: NCT02840084    
Other Study ID Numbers: G160087
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Non-identified data may be made available to the FDA if requested.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Nina S. Naidu, MD, Naidu, Nina S., M.D.:
breast implant capsular contracture
Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases