NCT05449587

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 111 (actual)
• Sponsor: Motiva USA LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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®."

Conditions

• Breast Augmentation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-07-08
• Last updated: 2024-10-31

Locations

2 sites across 1 country: Costa Rica