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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Alajuela Province
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Coyol, Alajuela Province, Costa Rica, 20113
- Establishment Labs
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Adverse Events Related to Tissue Preservation
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Patient-Reported Satisfaction Score (5-Point Likert Scale)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Patient-Reported Pain Score (Standardized Pain Scale)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CIP-001003
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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product vervaardigd in en geëxporteerd uit de V.S.
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