Capsular Contracture of Breast, Grade IIINCT02840084
Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture
A study testing Aspen(TM) Ultrasound System in people with Capsular Contracture of Breast, Grade III, run by Nina Naidu at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Capsular Contracture of Breast, Grade III
- What is being tested?
- Aspen(TM) Ultrasound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2019to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Aspen(TM) Ultrasound System
- Keywords
- breast implant capsular contracture
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspen(TM) Ultrasound SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Patients | Experimental | 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. Receives: Device: Aspen(TM) Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The determination of safety as defined by no adverse events, including implant rupture, skin burns,
Measured: 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
The documentation of efficacy as demonstrated by the reduction of at least one Baker Grade following treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start15 Sep 2019
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Why it stopped: adverse event
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsular Contracture of Breast, Grade IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nina Naidu
- Responsible party
- Sponsor-investigator, Nina Naidu, Naidu, Nina S., M.D.
- Investigators
- Nina Naidu, MD, Principal investigator, surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840084
- Sponsor's protocol ID
- G160087
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2016
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Non-identified data may be made available to the FDA if requested.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02840084
- Acronym / sponsor ID
- G160087
- Keywords
- breast implant capsular contracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: adverse event
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nina Naidu
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Patients | Experimental | Device: Aspen(TM) Ultrasound SystemIn 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 22 years or greater,
- Cosmetic breast augmentation,
- Baker Grade III capsular contracture, subglandular implant position, saline implants.
- Age 22 years or greater,
- Cosmetic breast augmentation,
Key exclusion criteria (25 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspen(TM) Ultrasound SystemTwo 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. | Device | Treatment Patients |
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.
Results and safety
The study was stopped early (reason given: adverse event). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Individual participant dataSharing planned: No. Non-identified data may be made available to the FDA if requested.
Related trials for Capsular Contracture of Breast, Grade III
Recruiting
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Naidu, MD principal investigator
surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspen(TM) Ultrasound System in people with Capsular Contracture of Breast, Grade III, run by Nina Naidu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: adverse event). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.