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Motiva Flora Tissue Expander PMCF

NCT05447988 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2024-08-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Breast Tissue Expander

tissue expander based breast reconstruction

Sponsors & Collaborators

  • Establishment Labs

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2024-12-15
Completion
2026-07-15

Countries

  • Chile
  • Costa Rica
  • Panama
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447988 on ClinicalTrials.gov