Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix

Last updated: October 29, 2024
Sponsor: Motiva USA LLC
Overall Status: Completed

Phase

N/A

Condition

Breast Reconstruction

Treatment

MRI and PRO

Clinical Study ID

NCT05449587
CLINP- 001010
  • Female
  • Accepts Healthy Volunteers

Study Summary

Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cisgender women.

  • The subject has undergone primary or revision augmentation surgery with MotivaImplants® Round or Round Ergonomix®, which are still implanted before enrolling inthe study.

  • The subject underwent breast implant surgery at least three (3) years or more beforeenrolling in the study.

  • The subject has undergone an MRI to evaluate implant rupture in the last 3 yearsbefore enrolling in the study or is willing to undergo an MRI evaluation.

  • The subject is willing to follow all study requirements (signing informed consent,completing questionnaires, attending a baseline visit, and allowing access toprevious MRI images or having new MRI images for the study).

Exclusion

Exclusion Criteria:

  • The subject had undergone fat grafting, needle biopsy, or any procedures that mighthave caused an iatrogenic rupture.

  • The Subject or Investigator are aware of a possible ruptured device that has notbeen removed.

  • The subject is pregnant or nursing.

  • The subject has any condition that impedes the use of Magnetic Resonance Imaging (MRI), including implanted metal devices, claustrophobia, or other conditions thatwould prohibit MRI scans.

Study Design

Total Participants: 111
Treatment Group(s): 1
Primary Treatment: MRI and PRO
Phase:
Study Start date:
November 22, 2022
Estimated Completion Date:
December 31, 2023

Study Description

Single-arm, multicenter study with a minimum of 160 subjects who underwent Breast Implant surgery from 3-10 years postoperatively.

Following IRB / EC approval - and if applicable Competent Authority approval - Magnetic Resonance Imaging (MRI) and Patient-Reported Outcome (PRO) with the validated BREAST-Q will be collected at a single time point for all enrolled subjects.

MRI data will be used for the analysis of silent rupture, and BREAST-Q Postoperative Augmentation module scales to record patients for satisfaction.

Two styles of Motiva Implants® will be used for this study:

  • Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round (referred to as "Motiva Implants® Round ProgressiveGel® Plus", or "Round")

  • Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round Ergonomix® (referred to as "Motiva Implants® Ergonomix® Round ProgressiveGel® Ultima®", or "Round Ergonomix").

Henceforth, these devices will generally be referenced as "Motiva Implants®."

Connect with a study center

  • Dr. Moradi´s Office

    Surry Hills, Sydney NSW 2010
    Australia

    Site Not Available

  • The Layt Clinic

    Brisbane, 4215
    Australia

    Site Not Available

  • Melbourne Institute of Plastic Surgery (MIPS)

    Melbourne, 3144
    Australia

    Site Not Available

  • Clinica de Cirugia Plastica Peralta Mantilla

    Pavas, San Jose 10109
    Costa Rica

    Site Not Available

  • Centro Europeo de Cirugia

    San Jose, 10108
    Costa Rica

    Site Not Available

  • Villa Bella Clinic

    Salò, BS 25087
    Italy

    Site Not Available

  • Instituto de Cirugía Plástica y Estética

    Madrid, 28006
    Spain

    Site Not Available

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