Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction

NCT07623564 | Enrolling By Invitation

• 1 other identifier: CIP-001003
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mammaplasty; Breast Augmentation; Tissue Preservation; Breast Augmentation and Breast Reconstruction

Keywords

Breast Augmentation; Breast Reconstruction; Minimally Invasive Surgery; Tissue Preservation; Mammaplasty; Mia Techniques; Motiva Implants; Surgical Innovation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day of surgery.

Secondary Outcomes (3)

• Patient-Reported Satisfaction Score (5-Point Likert Scale)

  Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.

• Surgeon-Reported Satisfaction Score (5-Point Likert Scale)

  Day of surgery.

• Rate of Postoperative Complications

  36 months post-surgery.

Other Outcomes (1)

• Patient-Reported Pain Score (Standardized Pain Scale)

  Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.

Study Arms (1)

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.

Procedure: Mia Harmonization; Procedure: Mia Scarless Lift; Procedure: Mia Reconstruction; Procedure: Joy Dot; Procedure: Maxtopexia + Mia

Interventions

Mia Harmonization PROCEDURE

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

Minimally Invasive Breast Surgery Cohort

Joy Dot PROCEDURE

Advanced augmentation method using specialized tools to preserve tissue integrity and minimize trauma.

Minimally Invasive Breast Surgery Cohort

Mia Scarless Lift PROCEDURE

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

Minimally Invasive Breast Surgery Cohort

Mia Reconstruction PROCEDURE

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

Minimally Invasive Breast Surgery Cohort

Maxtopexia + Mia PROCEDURE

Breast lift combining traditional techniques with advanced minimally invasive methods for tissue preservation.

Minimally Invasive Breast Surgery Cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Establishment Labs: lead

Study Sites (1)

Establishment Labs

Coyol, Alajuela Province, 20113, Costa Rica

Location

MeSH Terms

Interventions

MIA protein, human

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: June 3, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)