Breast AugmentationNCT06792409
Mia® Clinical Study
A study testing Minimally invasive breast augmentation procedure with a trans-axillary approach. in people with Breast Augmentation, run by Establishment Labs at 1 site in Costa Rica.
Trial summary
This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is. The women will have their first breast augmentation surgery using Motiva® Ergonomix2 Diamond® implants, Motiva Injector® and Motiva® Inflatable Balloon. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation
- What is being tested?
- Minimally invasive breast augmentation procedure with a trans-axillary approach.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCosta Rica
- Study dates
- 3 Dec 2020to 30 Dec 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Genetic females, ≥ 18 years.
- AA to C cup size, evaluated according to Triumph international guidelines.
- Participants with Class I and II risk according to the American Society of Anesthesiologists (ASA)
- Participants seeking a primary breast augmentation to increase the size of their breasts by one cup size.
- Body Mass Index between 18.5 and 24.9 (normal weight).
- Adequate tissue for covering the implant(s).
- Willingness to follow all study requirements and attending all necessary follow-up visits.
- Agreement to return the device to the sponsor in case it is explanted
Who cannot join
- Current costal lesions.
- Breast ptosis or poor skin quality.
- Inadequate tissue (for example, radiation damage, ulcers, compromised vascularity, history of inadequate wound scaring).
- History of abscesses or infections in the breast area.
- Currently pregnant or breastfeeding, or pregnancy or breastfeeding to term in the six months prior to recruitment.
- History of silicone sensitivity.
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- Use of any medications that interfere with coagulation or that may imply a high risk and/or significant post-surgical complication.
- Any medical condition, such as low weight or obesity according to the inclusion criteria, diabetes, autoimmune disease, chronic lung disease or serious cardiovascular disease that may result in an excessively high surgical risk and/or important post-surgical complications.
- Any condition that precludes the use of magnetic resonance imaging (MRI), including implanted metal devices, claustrophobia or other conditions that preclude MRI exploration.
- Any history of psychological characteristics that are not realistic or reasonable, considering the risks involved with the surgical procedure.
- Use of any medications that, according to the investigator, may imply a higher risk of complications or interference with wound healing ability, such as corticosteroids or anticoagulants (i.e., concomitant warfarin therapy).
- Current participation on studies for investigation devices or pharmaceutical products.
- Participants not residing in Costa Rica, which precludes their attendance to follow-up visits.
- Sponsor (or any of its subsidiaries) employees, study investigator or any person helping to conduct the study; direct (family) relationship with any sponsor (or any of its subsidiaries) or investigator employees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motiva Mia® Pilot Study to Evaluate the Safety and Initial Effectiveness of the Procedure and System Devices, Including Motiva Implants® Ergonomix2 Diamond® in Subjects Undergoing Primary Breast Augmentation Procedures
This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is. The women will have their first breast augmentation surgery using Motiva® Ergonomix2 Diamond® implants, Motiva Injector® and Motiva® Inflatable Balloon.
Read the detailed description
This is a prospective follow-up, 36-month, open, interventional study to confirm the safety and effectiveness of the procedure and system devices, including Motiva® Ergonomix2 Diamond® implants in women subjected to primary breast augmentation.
This study will enroll 100 women who will undergo a minimally invasive breast augmentation procedure with Ergonomix2 Diamond® using Motiva Injector® MIA and the Motiva MIA® inflatable balloon. The study duration will be 36 months and a six-month enrollment window was planned.
Recruitment will take place after enrollment and before any clinical research procedures, a participant will sign and date the Informed Consent Form. This will be considered the intent-to-treat (ITT) population. Since there will be a subset of women who will provide their consent to participate but will not undergo the procedure (i.e., due to a screening failure or consent withdrawal before the surgery, the analysis population for this study will be the full analysis set ("treated population") which will be made up by women that have received the implant(s) and that have at least one postop evaluation.
A Magnetic Resonance Imaging (MRI) substudy will be performed to determine the rate of silent rupture (no signs or symptoms) both extra- and intracapsular, and to identify displacement and/or gel fracture. MRI scans in this study will be performed on participants who are 18 to 21 months post-op. However, any study participant, whether or not participating in this sub study, who presents with signs or symptoms suggestive of a rupture, will be referred for MRI evaluation at any time during the study. Information obtained from the MRI study will be collected on the MRI Case Report Form by the investigator.
The proposed sample size of 33 participants in the MRI substudy, considered to be the industry standard, one third of the total sample participating in the Motiva MIA® study, and who consent to participate in this substudy.
- Conditions
- Breast Augmentation
- Being tested
- Minimally invasive breast augmentation procedure with a trans-axillary approach.
- Keywords
- Mia, Breast, augmentation, Minimally invasive, Transaxillar, Transaxillary, Motiva, Injector, Balloon, Inflatable Balloon, Ergonomix2, Implants, Dissector, Implant, Silicone, Diamond
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive breast augmentation procedure with a trans-axillary approach.Device
Also called Inflatable Balloon, Injector, Ergonomix breast implants
Minimally invasive breast augmentation procedure with a transaxillary approach using Motiva Ergonomix2 Diamond®, Motiva Injector® and Motiva® Inflatable Balloon.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive breast augmentation | Experimental | Minimally invasive breast augmentation procedure with a trans-axillary approach. Receives: Device: Minimally invasive breast augmentation procedure with a trans-axillary approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Cumulative incidence (number of cases) of adverse events during surgery and the follow-up period, severity and duration of all complications (rate of adverse events related to the procedure / adverse events related to the device).
Measured: From minimally invasive procedure through study completion, an average of 3 years.
Effectiveness
Effectiveness will be measured as satisfactory on all breast augmentation procedures using Mia® devices if no device failures have occurred.
Measured: From minimally invasive procedure through study completion, an average of 3 years.
Secondary outcomes (4)
Patient satisfaction
Percentage of participants in the BREAST-Q© augmentation model according to the scale.
Measured: From week 1 post-procedure to the end of the follow-up period
Patient satisfaction
Central trend (mean) of participants in the BREAST-Q© augmentation model according to the scale.
Measured: From week 1 post-procedure to the end of the follow-up period
Patient satisfaction
Variability (standard deviation) of participants in the BREAST-Q© augmentation model according to the scale.
Measured: From week 1 post-procedure to the end of the follow-up period
Surgeon satisfaction
Surgeon satisfaction with the results of the minimally invasive procedure using the satisfaction 5-item Likert scale, named Global Aesthetic Improvement Scale (GAIS).
Measured: During minimally invasive procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start3 Dec 2020
- Primary completion8 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Establishment Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792409
- Sponsor's protocol ID
- CLINP-001007 CR
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study is complete, the sponsor will analyze the data collected by the principal investigator and will conduct a scientific publication with all parties involved to unveil the study results.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motiva Mia® Pilot Study to Evaluate the Safety and Initial Effectiveness of the Procedure and System Devices, Including Motiva Implants® Ergonomix2 Diamond® in Subjects Undergoing Primary Breast Augmentation Procedures
- ClinicalTrials.gov ID
- NCT06792409
- Acronym / sponsor ID
- CLINP-001007 CR
- Conditions
- Breast Augmentation
- Keywords
- Mia, Breast, augmentation, Minimally invasive, Transaxillar, Transaxillary, Motiva, Injector
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 Jan 2025 (actual)
- 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.
This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is. The women will have their first breast augmentation surgery using Motiva® Ergonomix2 Diamond® implants, Motiva Injector® and Motiva® Inflatable Balloon.
Detailed description
This is a prospective follow-up, 36-month, open, interventional study to confirm the safety and effectiveness of the procedure and system devices, including Motiva® Ergonomix2 Diamond® implants in women subjected to primary breast augmentation.
This study will enroll 100 women who will undergo a minimally invasive breast augmentation procedure with Ergonomix2 Diamond® using Motiva Injector® MIA and the Motiva MIA® inflatable balloon. The study duration will be 36 months and a six-month enrollment window was planned.
Recruitment will take place after enrollment and before any clinical research procedures, a participant will sign and date the Informed Consent Form. This will be considered the intent-to-treat (ITT) population. Since there will be a subset of women who will provide their consent to participate but will not undergo the procedure (i.e., due to a screening failure or consent withdrawal before the surgery, the analysis population for this study will be the full analysis set ("treated population") which will be made up by women that have received the implant(s) and that have at least one postop evaluation.
A Magnetic Resonance Imaging (MRI) substudy will be performed to determine the rate of silent rupture (no signs or symptoms) both extra- and intracapsular, and to identify displacement and/or gel fracture. MRI scans in this study will be performed on participants who are 18 to 21 months post-op. However, any study participant, whether or not participating in this sub study, who presents with signs or symptoms suggestive of a rupture, will be referred for MRI evaluation at any time during the study. Information obtained from the MRI study will be collected on the MRI Case Report Form by the investigator.
The proposed sample size of 33 participants in the MRI substudy, considered to be the industry standard, one third of the total sample participating in the Motiva MIA® study, and who consent to participate in this substudy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive breast augmentation | Experimental | Device: Minimally invasive breast augmentation procedure with a trans-axillary approach.Minimally invasive breast augmentation procedure with a trans-axillary approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Genetic females, ≥ 18 years.
- AA to C cup size, evaluated according to Triumph international guidelines.
- Participants with Class I and II risk according to the American Society of Anesthesiologists (ASA)
- Participants seeking a primary breast augmentation to increase the size of their breasts by one cup size.
- Body Mass Index between 18.5 and 24.9 (normal weight).
Key exclusion criteria (14 listed)
- Current costal lesions.
- Breast ptosis or poor skin quality.
- Inadequate tissue (for example, radiation damage, ulcers, compromised vascularity, history of inadequate wound scaring).
- History of abscesses or infections in the breast area.
- Currently pregnant or breastfeeding, or pregnancy or breastfeeding to term in the six months prior to recruitment.
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 |
|---|---|---|
| Minimally invasive breast augmentation procedure with a trans-axillary approach.Also: Inflatable Balloon, Injector, Ergonomix breast implantsMinimally invasive breast augmentation procedure with a transaxillary approach using Motiva Ergonomix2 Diamond®, Motiva Injector® and Motiva® Inflatable Balloon. | Device | Minimally Invasive breast augmentation |
Primary outcome
Safety
Time frame: From minimally invasive procedure through study completion, an average of 3 years.
Cumulative incidence (number of cases) of adverse events during surgery and the follow-up period, severity and duration of all complications (rate of adverse events related to the procedure / adverse events related to the device).
Effectiveness
Time frame: From minimally invasive procedure through study completion, an average of 3 years.
Effectiveness will be measured as satisfactory on all breast augmentation procedures using Mia® devices if no device failures have occurred.
4 secondary outcomes
Patient satisfaction
Time frame: From week 1 post-procedure to the end of the follow-up period
Patient satisfaction
Time frame: From week 1 post-procedure to the end of the follow-up period
Patient satisfaction
Time frame: From week 1 post-procedure to the end of the follow-up period
Surgeon satisfaction
Time frame: During minimally invasive procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes. Once the study is complete, the sponsor will analyze the data collected by the principal investigator and will conduct a scientific publication with all parties involved to unveil the study results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive breast augmentation procedure with a trans-axillary approach. in people with Breast Augmentation, run by Establishment Labs at 1 site in Costa Rica.
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 14 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: finished, as of the sponsor's last update on 24 Jan 2025. 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 Costa Rica. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: From minimally invasive procedure through study completion, an average of 3 years.). 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 24 Jan 2025.