Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction (NCT07623564) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
Costa Rica60 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse Events Related to Tissue Preservation
Timeframe: 36 months post-surgery.
2
Rate of Intraoperative Tissue Integrity Preservation
. Mia Scarless Lift Specifics: Participants with mild, moderate, or pseudoptosis based on physician evaluation.
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:
. Medical History:
. 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).