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Enrolling By Invitation NCT07623564

Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction

Conditions: Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Establishment Labs

Location: Establishment Labs Coyol Alajuela Province

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 time, and improving aesthetic outcomes.

Eligibility Criteria

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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07623564). StuddyBuddy aggregates publicly available trial information.