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NCT03579901

Study of the Safety and Effectiveness of Motiva Implants®

Active, enrolled NA Last updated 12 November 2025
What this trial tests

NA trial testing Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants in Breast Implants in 800 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
6 April 2018
Primary endpoint
30 August 2032
28 February 2033

Quick facts

Lead sponsorMotiva USA LLC
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposeother
Enrollment800
Start date6 April 2018
Primary completion30 August 2032
Estimated completion28 February 2033
Sites29 locations across Sweden, United States, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Motiva USA LLC — full company profile →

Who can join

Adults 18 to 70, female only, with Breast Implants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Hydrogels in the clinic: An update.
    Clegg JR, Adebowale K, Zhao Z, Mitragotri S. · · 2024 · cited 64× · PMID 39545079 · DOI 10.1002/btm2.10680
  2. The Study of the Safety and Effectiveness of Motiva SmoothSilk Silicone Gel-Filled Breast Implants in Patients Undergoing Primary and Revisional Breast Augmentation: Three-Year Clinical Data.
    Glicksman C, Wolfe A, McGuire P. · · 2024 · cited 8× · PMID 39331509 · DOI 10.1093/asj/sjae134
  3. Ethical Considerations Regarding Financial Incentives in Plastic Surgery-Related Health Research.
    Gallo L, Gallo M, Yuan M, Voineskos SH, et al · · 2024 · cited 1× · PMID 39434809 · DOI 10.1177/22925503221151185

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Other Motiva USA LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03579901.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing