Last reviewed · How we verify
NCT03579901
Study of the Safety and Effectiveness of Motiva Implants®
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.
30 August 2032
Quick facts
| Lead sponsor | Motiva USA LLC |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 800 |
| Start date | 6 April 2018 |
| Primary completion | 30 August 2032 |
| Estimated completion | 28 February 2033 |
| Sites | 29 locations across Sweden, United States, Germany |
Drugs / interventions tested
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Conditions studied
- Breast Implants — all drugs for Breast Implants →
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):
-
Hydrogels in the clinic: An update.
Clegg JR, Adebowale K, Zhao Z, Mitragotri S. · · 2024 · cited 64× · PMID 39545079 · DOI 10.1002/btm2.10680 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03579901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Motiva USA LLC trials
Trials by the same sponsor.
- NCT06938399 — Motiva Implants® Post-Approval Study · NA · recruiting
- NCT05449587 — Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03579901 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Motiva USA LLC
- Last refreshed: 12 November 2025
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