Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction

N/AEnrolling By InvitationNCT07623564

Establishment Labs60 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Breast Augmentation and Breast Reconstruction Mammaplasty Breast Augmentation Tissue Preservation

Interventions

Mia HarmonizationPROCEDURE

Minimally invasive technique for breast augmentation, increasing volume while preserving natural tissue.

Mia Scarless LiftPROCEDURE

Minimally invasive breast lift for mild to moderate ptosis without visible scarring.

Mia ReconstructionPROCEDURE

Reconstructive technique for restoring breast contour and volume after benign surgical interventions.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Gender and Age: Cisgender women, aged 18 years or older. 2. 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 3. Breast Size: Cup sizes AA to C, as determined by guidelines from Triumph International. 4. Health Status: ASA (American Society of Anesthesiologists) classification I or II. 5. Tissue Integrity: Adequate breast tissue available to cover the implant(s). 6. Commitment: Willingness to adhere to all study requirements, including follow-up visits and signing the informed consent form. 7. Special Cases for Reconstruction: Participants with congenital or acquired breast or thoracic conditions, such as amastia, pectus excavatum/carinatum, tuberous breasts, or asymmetry. 8. Mia Scarless Lift Specifics: Participants with mild, moderate, or pseudoptosis based on physician evaluation. 9. Timing: Women scheduled for surgery at the Sulàyöm Innovation Campus between January and December 2025. Exclusion Criteria: 1. 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). 2. Non-Study Implants: Use of implants other than Motiva products. 3. Compromised Tissue or Skin: * Existing rib lesions or significant/severe breast ptosis. * Poor tissue quality due to radiation damage, vascular compromise, or prior ulceration. 4. Medical History: * History of breast abscesses or infections. * Sensitivity or allergy to silicone. 5. Current Physiological Conditions: -Pregnancy or breastfeeding, or within six months postpartum or post-lactation. 6. Medications: Use of anticoagulants or medications that impair wound healing (e.g., corticosteroids, Warfarin). 7. Imaging Constraints: Conditions that prevent the use of MRI (e.g., implanted metal devices, claustrophobia). 8. Concurrent Research: Participation in another clinical research study involving drugs or devices. 9. Follow-Up Barriers: Residency outside Costa Rica or inability to attend required follow-up visits. 10. Timing Issues: Participants undergoing surgery outside the designated study period (January to December 2025).

Locations (1)

Establishment Labs

Coyol, Alajuela Province, Costa Rica

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Day of surgery.

Secondary Outcomes

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.

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)

Mean score and distribution of surgeon-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale.

Time frame: Day of surgery.

Rate of Postoperative Complications

Incidence rate (%) of postoperative complications, including fibrosis, capsular contracture, and scarring, during the follow-up period.

Time frame: 36 months post-surgery.

Data from ClinicalTrials.gov

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