Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
Post-Marketing Clinical Follow-Up Study on Tissue Preservation Techniques in Breast Augmentation and Reconstruction.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
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Alajuela Province
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Coyol, Alajuela Province, Kostaryka, 20113
- Establishment Labs
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
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.
Opis
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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:
- 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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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.
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Minimally invasive technique for breast augmentation, increasing volume while preserving natural tissue.
Minimally invasive breast lift for mild to moderate ptosis without visible scarring.
Reconstructive technique for restoring breast contour and volume after benign surgical interventions.
Advanced augmentation method using specialized tools to preserve tissue integrity and minimize trauma.
Breast lift combining traditional techniques with advanced minimally invasive methods for tissue preservation.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Adverse Events Related to Tissue Preservation
Ramy czasowe: 36 months post-surgery.
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The cumulative occurrence of adverse events, such as necrosis, hematoma, infection, or tissue damage, associated with the surgical procedures.
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36 months post-surgery.
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Rate of Intraoperative Tissue Integrity Preservation
Ramy czasowe: Day of surgery.
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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.
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Day of surgery.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Patient-Reported Satisfaction Score (5-Point Likert Scale)
Ramy czasowe: Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
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Mean score and distribution of patient-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale.
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Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
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Surgeon-Reported Satisfaction Score (5-Point Likert Scale)
Ramy czasowe: Day of surgery.
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Mean score and distribution of surgeon-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale.
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Day of surgery.
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Rate of Postoperative Complications
Ramy czasowe: 36 months post-surgery.
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Incidence rate (%) of postoperative complications, including fibrosis, capsular contracture, and scarring, during the follow-up period.
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36 months post-surgery.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Patient-Reported Pain Score (Standardized Pain Scale)
Ramy czasowe: Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
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Mean patient-reported pain score measured using a standardized pain scale at each follow-up visit.
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Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CIP-001003
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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