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

Sponsor

Motiva USA LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05449587

Collaborator

(none)

120

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation	Other: MRI and PRO

Detailed Description

Single-arm, multicenter study with a minimum of 120 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®."

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Primary /Revision Augmentation Cohort Patients that underwent primary and/or revision augmentation from 3-10 years postoperatively.	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

Arm

Intervention/Treatment

Primary /Revision Augmentation Cohort

Patients that underwent primary and/or revision augmentation from 3-10 years postoperatively.

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

Outcome Measures

Primary Outcome Measures

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. [1 year to complete after study start.]
Percentage of participants with silent implant rupture identified on MRI evaluation.
To describe Patient-Reported Outcomes in women who have undergone primary and revision breast augmentation with Motiva Implants® 3 to 10 years after surgery. [1 year to complete after study start]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Genetic women.
The subject has undergone primary augmentation or revision augmentation surgery with Motiva Implants Round or Round Ergonomix®.
The subject underwent breast implant surgery 3-10 years before enrolling in the study.
The subject has undergone an MRI to evaluate implant rupture in the last 2-3 years before enrolling in the study or is willing to undergo an MRI evaluation.
The subject is willing to follow all study requirements (pre-screening, baseline visit, signing the ICF, and completing the BREAST-Q questionnaires).

Exclusion Criteria:

The subject had undergone fat grafting, needle biopsy, or any procedures that might have caused an iatrogenic rupture.
The Subject or Investigator is 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 make MRI scan prohibited.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Moradi´s Office	Surry Hills	Sydney	Australia	NSW 2010
2	Clinica de Cirugia Plastica Peralta Mantilla	Pavas	San Jose	Costa Rica	10109
3	Centro Europeo de Cirugia	San Jose		Costa Rica	10108
4	Villa Bella Clinic	Salò	BS	Italy	25087
5	Instituto de Cirugía Plástica y Estética	Madrid		Spain	28006