Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05449587




Registration number
NCT05449587
Ethics application status
Date submitted
15/03/2022
Date registered
8/07/2022
Date last updated
14/03/2023

Titles & IDs
Public title
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Scientific title
Study of the Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix in Primary and Revision Breast Augmentation
Secondary ID [1] 0 0
CLINP- 001010
Universal Trial Number (UTN)
Trial acronym
MIRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Augmentation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - MRI and PRO

Primary /Revision Augmentation Cohort - Patients that underwent primary and/or revision augmentation from 3 years or more postoperatively.


Other interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 year to complete after study start.
Primary outcome [2] 0 0
To describe Patient-Reported Outcomes in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery.
Timepoint [2] 0 0
1 year to complete after study start

Eligibility
Key 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).
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Sydne
Recruitment hospital [1] 0 0
Dr. Moradi´s Office - Surry Hills
Recruitment hospital [2] 0 0
The Layt Clinic - Brisbane
Recruitment hospital [3] 0 0
Melbourne Institute of Plastic Surgery (MIPS) - Melbourne
Recruitment postcode(s) [1] 0 0
NSW 2010 - Surry Hills
Recruitment postcode(s) [2] 0 0
4215 - Brisbane
Recruitment postcode(s) [3] 0 0
3144 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Costa Rica
State/province [1] 0 0
San Jose
Country [2] 0 0
Italy
State/province [2] 0 0
BS
Country [3] 0 0
Spain
State/province [3] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Motiva USA LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05449587
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ana Vega, MD
Address 0 0
Country 0 0
Phone 0 0
(506) 2434-2400
Fax 0 0
Email 0 0
miro@establishmentlabs.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05449587