Study of the Safety and Effectiveness of Motiva Implants®

Breast Implants Clinical Trial

Official title:
Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery

Status Active, not recruiting

Clinical Trial Summary

This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

Clinical Trial Description

Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years. ;

Study Design

Related Conditions & MeSH terms

Breast Implants

Clinical Trial Details

NCT number	NCT03579901
Study type	Interventional
Source	Motiva USA LLC
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 6, 2018
Completion date	February 28, 2033

View Details

See also
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Withdrawn	`NCT01857765` - Breast Augmentation Rehabilitation Program	N/A
Recruiting	`NCT06147661` - Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
Completed	`NCT00858052` - Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants	N/A
Completed	`NCT01874652` - Assessment of Safety & Efficacy of Light Weight Breast Implant	Phase 2