Clinical trial · Observational
Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months. All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander. The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motiva Flora TE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Safety - adverse events
- timeFrame
- Until finalization of staged Breast reconstruction, approximately 6 months
- description
- Cumulative incidence and causal relationship with the device of adverse events (AEs) reported by the surgeon. This includes known complications as listed in the IFU, as well as any other adverse events, seen as at least possibly related to the device according to the surgeon.
- measure
- Safety - device deficiencies
- timeFrame
- Until finalization of staged Breast reconstruction, approximately 6 months
- description
- Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.
- measure
- Performance - succesful implant of long-term breast implant
- timeFrame
- Until finalization of staged Breast reconstruction, approximately 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE . * Patient has been informed correctly according to to the applicable national and local regulations. Exclusion Criteria: * Not applicable
References
Publications (0)
Data not yet available