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.
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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

Catalina Solano

+506-83112829

csolano@establishmentlabs.com

CONTACT

Jorge Villalobos

+506-8839 6446

jvillalobosa@establishmentlabs.com

CONTACT