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Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction

NCT05459064 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2024-08-27

No results posted yet for this study

Summary

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

Interventions

DEVICE

Motiva Flora TE

This is a retrospective, observational study - collecting data on patients who have gone through the staged procedure with the Motiva Flora Tissue Expander / Long-term breast implant.

Sponsors & Collaborators

  • Establishment Labs

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Belgium
  • 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 NCT05459064 on ClinicalTrials.gov