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

Breast Augmentation Clinical Trial

— MIRO  

Official title:

Study of the Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix in Primary and Revision Breast Augmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449587
• Other study ID #: CLINP- 001010
• Status: Recruiting
• Start date: November 22, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Motiva USA LLC
• Contact: Ana Vega, MD
• Phone: (506) 2434-2400
• Email: miro[@]establishmentlabs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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®."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cisgender women.
• The subject has undergone primary or revision augmentation surgery with Motiva Implants® Round or Round Ergonomix®, which are still implanted before enrolling in the study.
• The subject underwent breast implant surgery at least three (3) years or more before enrolling in the study.
• The subject has undergone an MRI to evaluate implant rupture in the last 3 years before 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 to previous MRI images or having new MRI images for the study).

Exclusion Criteria:

• The subject had undergone fat grafting, needle biopsy, or any procedures that might have caused an iatrogenic rupture.
• The Subject or Investigator are aware of a possible ruptured device that has not been 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 that would prohibit MRI scans.

Related Conditions & MeSH terms

• Breast Augmentation

Intervention

Other:
• MRI and PRO
MRI as a standard of care for the analysis of silent rupture. BREAST-Q Postoperative Augmentation module scales to record patients for satisfaction: Satisfaction with breasts; Satisfaction with outcome; Psychosocial well-being; Physical well-being

Locations

Country	Name	City	State
Australia	The Layt Clinic	Brisbane
Australia	Melbourne Institute of Plastic Surgery (MIPS)	Melbourne
Australia	Dr. Moradi´s Office	Surry Hills	Sydney
Costa Rica	Clinica de Cirugia Plastica Peralta Mantilla	Pavas	San Jose
Costa Rica	Centro Europeo de Cirugia	San Jose
Italy	Villa Bella Clinic	Salò	BS
Spain	Instituto de Cirugía Plástica y Estética	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Motiva USA LLC

Countries where clinical trial is conducted

Australia,  Costa Rica,  Italy,  Spain, 

References & Publications (5)

Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-Term Safety of Textured and Smooth Breast Implants. Aesthet Surg J. 2017 Dec 13;38(1):38-48. doi: 10.1093/asj/sjx157. — View Citation

Meadows KA. Patient-reported outcome measures: an overview. Br J Community Nurs. 2011 Mar;16(3):146-51. doi: 10.12968/bjcn.2011.16.3.146. — View Citation

Ray JG, Vermeulen MJ, Bharatha A, Montanera WJ, Park AL. Association Between MRI Exposure During Pregnancy and Fetal and Childhood Outcomes. JAMA. 2016 Sep 6;316(9):952-61. doi: 10.1001/jama.2016.12126. — View Citation

Wong T, Lo LW, Fung PY, Lai HY, She HL, Ng WK, Kwok KM, Lee CM. Magnetic resonance imaging of breast augmentation: a pictorial review. Insights Imaging. 2016 Jun;7(3):399-410. doi: 10.1007/s13244-016-0482-9. Epub 2016 Mar 9. — View Citation

Zingaretti, Nicola & Fasano, Daniele & Preis, Franz & Moreschi, Carlo & Ricci, Silvia & Massarut, Samuele & De Francesco, Francesco & Parodi, Pier. (2020). Suspected breast implant rupture: our experience, recommendations on its management, and a proposal for a model of informed consent. European Journal of Plastic Surgery. 43. 10.1007/s00238-019-01610-1.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the rate of silent rupture in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery.	Percentage of participants with silent implant rupture identified on MRI evaluation.	1 year to complete after study start.
Primary	To describe Patient-Reported Outcomes in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery.	Mean scores of the BBREAST-QTM - AUGMENTATION MODULE (POSTOPERATIVE) VERSION 2.0, scales: PSYCHOSOCIAL WELL-BEING. Values 1-5. A higher score means a better outcome.; SATISFACTION WITH BREASTS. Values 1-4. A higher score means a better outcome.; PHYSICAL WELL-BEING: CHEST. Values 1-3. A higher score means a worse outcome.; SATISFACTION WITH OUTCOME. Values 1-3. A higher score means a better outcome.	1 year to complete after study start