Last reviewed · How we verify
NCT06851494: LinneaSafe30
Safety and Efficacy of Linnea Safe PMMA 30% Use for Gluteal Augmentation.
NA trial testing PMMA in Gluteal Augmentation in 137 participants. Not yet recruiting.
1 November 2026
Quick facts
| Lead sponsor | LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA. |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 137 |
| Start date | 1 November 2025 |
| Primary completion | 1 November 2026 |
| Estimated completion | 1 November 2026 |
Drugs / interventions tested
- PMMA — full drug profile →
Conditions studied
- Gluteal Augmentation — all drugs for Gluteal Augmentation →
Sponsor
LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.
Who can join
18 and older, any sex, with Gluteal Augmentation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pre-market, interventional, single-arm study aims to evaluate the safety and efficacy of LinneaSafe 30% polymethylmethacrylate (PMMA) for gluteal augmentation. The study will include 119 patients, with a total recruitment of 137 to account for a 15% drop-out rate. Eligible participants are men and women over 18 years old who express interest and are deemed suitable for the procedure. The primary safety outcome is the incidence of adverse events, while the primary efficacy outcome is patient satisfaction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06851494
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06851494 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LEBON PRODUTOS QUIMICOS E FARMACEUTICOS LTDA.
- Last refreshed: 4 March 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/NCT06851494.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing