Motiva Flora Tissue Expander PMCF
Recruiting
N/A
Interventional Study
Breast Tissue Accessory
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 136 (estimated)
- Sponsor
- Establishment Labs · Industry
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About This Trial
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, Co…
Trial Locations
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Eligibility Criteria
Inclusion Criteria
* The participant gives written informed consent.
* The participant is genetically female, aged 18 years or older.
* The participant needs tissue expansion as part of breast reconstruction treatment following mastectomy, which may include immediate reconstruction.
* The participa…
Contacts