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

NCT05449587 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2024-10-31

No results posted yet for this 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.

Conditions

  • Breast Augmentation

Interventions

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

Sponsors & Collaborators

  • Motiva USA LLC

    lead INDUSTRY

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Costa Rica

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449587 on ClinicalTrials.gov