Breast Augmentation and Breast ReconstructionNCT07623564
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
An observational study of Breast Augmentation and Breast Reconstruction and Mammaplasty, run by Establishment Labs at 1 site in Costa Rica.
Trial summary
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction. These methods, known as Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia, focus on preserving breast tissue, reducing recovery… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation
- What is being tested?
- Mia Harmonization, Mia Scarless Lift and Mia Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCosta Rica
- Study dates
- 1 May 2025to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises approximately 60 cisgender women aged 18 years or older who will undergo minimally invasive breast augmentation or benign reconstruction procedures at the Sulàyöm Innovation Campus in Costa Rica. Eligible participants will include women with breast cup sizes ranging from AA to C, classified as ASA I or II, and with sufficient breast tissue to support implant placement. The cohort will include individuals undergoing the following procedures: * Mia Harmonization * Mia Scarless Lift * Mia Reconstruction * Joy Dot * Maxtopexia + Mia Additionally, participants may have congenital or acquired breast conditions (e.g., amastia, tuberous breasts, asymmetry) and meet the specific inclusion criteria for these advanced minimally invasive techniques. Recruitment will focus on women scheduled for surgery between January and December 2025, with follow-up spanning 36 months. Participants must reside in Costa Rica to ensure adherence to follow-up visits.
Who may be able to join
- Gender and Age: Cisgender women, aged 18 years or older.
- Surgical Procedure: Participants undergoing primary breast augmentation or benign reconstruction using the following minimally invasive procedures:
- Mia Harmonization
- Mia Scarless Lift
- Mia Reconstruction
- Joy Dot
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- Maxtopexia + Mia
- Breast Size: Cup sizes AA to C, as determined by guidelines from Triumph International.
- Health Status: ASA (American Society of Anesthesiologists) classification I or II.
- Tissue Integrity: Adequate breast tissue available to cover the implant(s).
- Commitment: Willingness to adhere to all study requirements, including follow-up visits and signing the informed consent form.
- Special Cases for Reconstruction: Participants with congenital or acquired breast or thoracic conditions, such as amastia, pectus excavatum/carinatum, tuberous breasts, or asymmetry.
- Mia Scarless Lift Specifics: Participants with mild, moderate, or pseudoptosis based on physician evaluation.
- Timing: Women scheduled for surgery at the Sulàyöm Innovation Campus between January and December 2025.
Who cannot join
- Non-Specified Procedures: Women undergoing augmentation or reconstruction with techniques other than those listed (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, Maxtopexia + Mia).
- Non-Study Implants: Use of implants other than Motiva products.
- Compromised Tissue or Skin:
- Existing rib lesions or significant/severe breast ptosis.
- Poor tissue quality due to radiation damage, vascular compromise, or prior ulceration.
- Medical History:
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- History of breast abscesses or infections.
- Sensitivity or allergy to silicone.
- Current Physiological Conditions:
- -Pregnancy or breastfeeding, or within six months postpartum or post-lactation.
- Medications: Use of anticoagulants or medications that impair wound healing (e.g., corticosteroids, Warfarin).
- Imaging Constraints: Conditions that prevent the use of MRI (e.g., implanted metal devices, claustrophobia).
- Concurrent Research: Participation in another clinical research study involving drugs or devices.
- Follow-Up Barriers: Residency outside Costa Rica or inability to attend required follow-up visits.
- Timing Issues: Participants undergoing surgery outside the designated study period (January to December 2025).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post-Marketing Clinical Follow-Up Study on Tissue Preservation Techniques in Breast Augmentation and Reconstruction.
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction. These methods, known as Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia, focus on preserving breast tissue, reducing recovery time, and improving aesthetic outcomes.
Read the detailed description
This post-marketing observational study evaluates the safety and efficacy of innovative, minimally invasive breast augmentation and reconstruction techniques: Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia. These techniques aim to enhance tissue preservation, minimize scarring, and promote quicker recovery compared to traditional methods.
The study will enroll 60 participants undergoing these procedures at the Sulàyöm Innovation Campus in Costa Rica between January and December 2025. Participants will be followed for 36 months to monitor complication rates, tissue health, and satisfaction. Procedures utilize advanced devices like the Motiva Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, and Motiva® Reusable Channel Separator, designed to optimize outcomes while preserving natural breast structures.
Key assessments include:
Safety Metrics: Monitoring adverse events, such as tissue necrosis, hematoma, or infection, through regular follow-ups.
Efficacy Metrics: Evaluating tissue preservation during and after surgery using imaging and clinical assessments.
Patient and Surgeon Satisfaction: Measuring perceptions of outcomes and procedure success using validated scales.
The study will also conduct a temperature monitoring substudy using the Motiva® Zen transponder to assess its functionality in recording implant temperature. This optional component enhances understanding of implant safety.
Results will provide crucial insights into the role of minimally invasive techniques in improving breast surgery outcomes, focusing on safety, tissue preservation, and patient satisfaction. These findings will inform future surgical practices and technological advancements.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Being tested
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, Maxtopexia + Mia
- Keywords
- Breast Augmentation, Breast Reconstruction, Minimally Invasive Surgery, Tissue Preservation, Mammaplasty, Mia Techniques, Motiva Implants, Surgical Innovation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mia HarmonizationProcedure or surgery
Minimally invasive technique for breast augmentation, increasing volume while preserving natural tissue.
Mia Scarless LiftProcedure or surgery
Minimally invasive breast lift for mild to moderate ptosis without visible scarring.
Mia ReconstructionProcedure or surgery
Reconstructive technique for restoring breast contour and volume after benign surgical interventions.
Joy DotProcedure or surgery
Advanced augmentation method using specialized tools to preserve tissue integrity and minimize trauma.
Maxtopexia + MiaProcedure or surgery
Breast lift combining traditional techniques with advanced minimally invasive methods for tissue preservation.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Breast Surgery Cohort | This single cohort consists of approximately 60 women undergoing one of the minimally invasive breast augmentation or reconstruction procedures (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, or Maxtopexia + Mia) at the Sulàyöm Innovation Campus. Data from all participants will be analyzed collectively to evaluate the safety, efficacy, and outcomes of these procedures. Receives: Procedure: Mia Harmonization; Procedure: Mia Scarless Lift; Procedure: Mia Reconstruction; Procedure: Joy Dot; Procedure: Maxtopexia + Mia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Related to Tissue Preservation
The cumulative occurrence of adverse events, such as necrosis, hematoma, infection, or tissue damage, associated with the surgical procedures.
Measured: 36 months post-surgery.
Rate of Intraoperative Tissue Integrity Preservation
Proportion (%) of surgical procedures in which intraoperative tissue integrity is maintained (no damage observed), and incidence rate (%) of tissue damage events during surgery, as assessed intraoperatively.
Measured: Day of surgery.
Secondary outcomes (3)
Patient-Reported Satisfaction Score (5-Point Likert Scale)
Mean score and distribution of patient-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale.
Measured: Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
Surgeon-Reported Satisfaction Score (5-Point Likert Scale)
Mean score and distribution of surgeon-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale.
Measured: Day of surgery.
Rate of Postoperative Complications
Incidence rate (%) of postoperative complications, including fibrosis, capsular contracture, and scarring, during the follow-up period.
Measured: 36 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Augmentation and Breast ReconstructionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Establishment Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623564
- Sponsor's protocol ID
- CIP-001003
- Status last verified
- May 2026
- First submitted
- 20 Aug 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared to ensure the confidentiality and privacy of participants. Since the study collects sensitive clinical data, strict measures are in place to protect participant identities. Data will be securely stored in a de-identified and encrypted format, accessible only to authorized research personnel. This approach aligns with ethical standards and local regulations, such as Costa Rica's Ley de Investigación Biomédica (Law 9234), which prioritizes the protection of participants' personal information. Additionally, as this is an observational study with no direct interventions, the value of sharing IPD for broader scientific purposes is limited compared to the aggregate analysis and results.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-Up Study on Tissue Preservation Techniques in Breast Augmentation and Reconstruction.
- ClinicalTrials.gov ID
- NCT07623564
- Acronym / sponsor ID
- CIP-001003
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Keywords
- Breast Augmentation, Breast Reconstruction, Minimally Invasive Surgery, Tissue Preservation, Mammaplasty, Mia Techniques, Motiva Implants, Surgical Innovation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 3 Jun 2026 (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 clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction. These methods, known as Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia, focus on preserving breast tissue, reducing recovery time, and improving aesthetic outcomes.
Detailed description
This post-marketing observational study evaluates the safety and efficacy of innovative, minimally invasive breast augmentation and reconstruction techniques: Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, and Maxtopexia + Mia. These techniques aim to enhance tissue preservation, minimize scarring, and promote quicker recovery compared to traditional methods.
The study will enroll 60 participants undergoing these procedures at the Sulàyöm Innovation Campus in Costa Rica between January and December 2025. Participants will be followed for 36 months to monitor complication rates, tissue health, and satisfaction. Procedures utilize advanced devices like the Motiva Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, and Motiva® Reusable Channel Separator, designed to optimize outcomes while preserving natural breast structures.
Key assessments include:
Safety Metrics: Monitoring adverse events, such as tissue necrosis, hematoma, or infection, through regular follow-ups.
Efficacy Metrics: Evaluating tissue preservation during and after surgery using imaging and clinical assessments.
Patient and Surgeon Satisfaction: Measuring perceptions of outcomes and procedure success using validated scales.
The study will also conduct a temperature monitoring substudy using the Motiva® Zen transponder to assess its functionality in recording implant temperature. This optional component enhances understanding of implant safety.
Results will provide crucial insights into the role of minimally invasive techniques in improving breast surgery outcomes, focusing on safety, tissue preservation, and patient satisfaction. These findings will inform future surgical practices and technological advancements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Breast Surgery Cohort | – | Procedure: Mia Harmonization, Procedure: Mia Scarless Lift, Procedure: Mia Reconstruction, Procedure: Joy Dot, Procedure: Maxtopexia + MiaThis single cohort consists of approximately 60 women undergoing one of the minimally invasive breast augmentation or reconstruction procedures (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, or Maxtopexia + Mia) at the Sulàyöm Innovation Campus. Data from all participants will be analyzed collectively to evaluate the safety, efficacy, and outcomes of these procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises approximately 60 cisgender women aged 18 years or older who will undergo minimally invasive breast augmentation or benign reconstruction procedures at the Sulàyöm Innovation Campus in Costa Rica. Eligible participants will include women with breast cup sizes ranging from AA to C, classified as ASA I or II, and with sufficient breast tissue to support implant placement. The cohort will include individuals undergoing the following procedures: * Mia Harmonization * Mia Scarless Lift * Mia Reconstruction * Joy Dot * Maxtopexia + Mia Additionally, participants may have congenital or acquired breast conditions (e.g., amastia, tuberous breasts, asymmetry) and meet the specific inclusion criteria for these advanced minimally invasive techniques. Recruitment will focus on women scheduled for surgery between January and December 2025, with follow-up spanning 36 months. Participants must reside in Costa Rica to ensure adherence to follow-up visits.
Key inclusion criteria (14 listed)
- Gender and Age: Cisgender women, aged 18 years or older.
- Surgical Procedure: Participants undergoing primary breast augmentation or benign reconstruction using the following minimally invasive procedures:
- Breast Size: Cup sizes AA to C, as determined by guidelines from Triumph International.
- Health Status: ASA (American Society of Anesthesiologists) classification I or II.
- Tissue Integrity: Adequate breast tissue available to cover the implant(s).
Key exclusion criteria (15 listed)
- Non-Specified Procedures: Women undergoing augmentation or reconstruction with techniques other than those listed (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, Maxtopexia + Mia).
- Non-Study Implants: Use of implants other than Motiva products.
- Compromised Tissue or Skin:
- Medical History:
- Current Physiological Conditions:
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 |
|---|---|---|
| Mia HarmonizationMinimally invasive technique for breast augmentation, increasing volume while preserving natural tissue. | Procedure or surgery | Minimally Invasive Breast Surgery Cohort |
| Mia Scarless LiftMinimally invasive breast lift for mild to moderate ptosis without visible scarring. | Procedure or surgery | Minimally Invasive Breast Surgery Cohort |
| Mia ReconstructionReconstructive technique for restoring breast contour and volume after benign surgical interventions. | Procedure or surgery | Minimally Invasive Breast Surgery Cohort |
| Joy DotAdvanced augmentation method using specialized tools to preserve tissue integrity and minimize trauma. | Procedure or surgery | Minimally Invasive Breast Surgery Cohort |
| Maxtopexia + MiaBreast lift combining traditional techniques with advanced minimally invasive methods for tissue preservation. | Procedure or surgery | Minimally Invasive Breast Surgery Cohort |
Primary outcome
Number of Adverse Events Related to Tissue Preservation
Time frame: 36 months post-surgery.
The cumulative occurrence of adverse events, such as necrosis, hematoma, infection, or tissue damage, associated with the surgical procedures.
Rate of Intraoperative Tissue Integrity Preservation
Time frame: Day of surgery.
Proportion (%) of surgical procedures in which intraoperative tissue integrity is maintained (no damage observed), and incidence rate (%) of tissue damage events during surgery, as assessed intraoperatively.
3 secondary outcomes
Patient-Reported Satisfaction Score (5-Point Likert Scale)
Time frame: Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
Surgeon-Reported Satisfaction Score (5-Point Likert Scale)
Time frame: Day of surgery.
Rate of Postoperative Complications
Time frame: 36 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared to ensure the confidentiality and privacy of participants. Since the study collects sensitive clinical data, strict measures are in place to protect participant identities. Data will be securely stored in a de-identified and encrypted format, accessible only to authorized research personnel. This approach aligns with ethical standards and local regulations, such as Costa Rica's Ley de Investigación Biomédica (Law 9234), which prioritizes the protection of participants' personal information. Additionally, as this is an observational study with no direct interventions, the value of sharing IPD for broader scientific purposes is limited compared to the aggregate analysis and 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.
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?
An observational study of Breast Augmentation and Breast Reconstruction and Mammaplasty, 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 14 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Adverse Events Related to Tissue Preservation (time frame: 36 months post-surgery.). 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 3 Jun 2026.