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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Alajuela Province
-
Coyol, Alajuela Province, Costa Rica, 20113
- Establishment Labs
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Adverse Events Related to Tissue Preservation
Aikaikkuna: 36 months post-surgery.
|
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
Aikaikkuna: Day of surgery.
|
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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Patient-Reported Satisfaction Score (5-Point Likert Scale)
Aikaikkuna: Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
|
Mean score and distribution of patient-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 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)
Aikaikkuna: Day of surgery.
|
Mean score and distribution of surgeon-reported satisfaction with breast appearance, natural feel, and symmetry, measured using a 5-point Likert scale.
|
Day of surgery.
|
|
Rate of Postoperative Complications
Aikaikkuna: 36 months post-surgery.
|
Incidence rate (%) of postoperative complications, including fibrosis, capsular contracture, and scarring, during the follow-up period.
|
36 months post-surgery.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Patient-Reported Pain Score (Standardized Pain Scale)
Aikaikkuna: Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
|
Mean patient-reported pain score measured using a standardized pain scale at each follow-up visit.
|
Baseline and follow-ups at 1, 3, 6, 12, 24, and 36 months post-surgery.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CIP-001003
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .