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NCT05447988
Motiva Flora Tissue Expander PMCF
NA trial testing Breast Tissue Expander in Breast Tissue Accessory in 136 participants. Currently enrolling.
15 December 2024
Quick facts
| Lead sponsor | Establishment Labs |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 136 |
| Start date | 14 December 2020 |
| Primary completion | 15 December 2024 |
| Estimated completion | 15 July 2026 |
| Sites | 5 locations across Chile, Costa Rica, Spain, Panama |
Drugs / interventions tested
- Breast Tissue Expander
Conditions studied
- Breast Tissue Accessory — all drugs for Breast Tissue Accessory →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Establishment Labs — full company profile →
Who can join
18 and older, female only, with Breast Tissue Accessory or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery. The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05447988
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Establishment Labs trials
Trials by the same sponsor.
- NCT06274736 — Safety and Performance of Motiva® Sizers · recruiting
- NCT05459064 — Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction · completed
- NCT06792409 — Mia® Clinical Study · NA · 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 NCT05447988 (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 Establishment Labs
- Last refreshed: 27 August 2024
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/NCT05447988.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing