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RECRUITINGNA

Motiva Flora Tissue Expander PMCF

Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery

NCT05447988•Establishment Labs

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 participant is in a suitable clinical condition to allow breast implant placement after tissue expander placement, at the discretion of the investigator.
•The participant has the physical and cognitive capacity to understand and follow the surgeon's recommendations.
•Complete radiotherapy at least 1 year before surgery.
•Partial or total decrease in tumour volume after radiotherapy.
•The participant is able and willing to comply with all study requirements including attending follow-up appointments.
•Participant with reasonable surgical risk.
•Participant with a history of non-metastatic breast cancer.
+3 more criteria

Exclusion Criteria

•The participant is pregnant or planning a pregnancy during the first year after surgery or is currently breastfeeding.
•Participants with implanted devices that may be affected by magnetic fields (pacemakers, drug infusion devices).
•Participants with abnormal haematological and biochemical values after chemotherapy.
•Participants with tumour residues in or near the area where tissue expansion is to be performed.
•Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing or scar deformity.
•Participants with current or previous infection in the area where the expansion will take place.
•Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
•Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts or radical resection of the pectoralis major muscle.
•Participant who is included in another pharmacological or device research study.
•Participants with a previous history of failure of attempted tissue expansion or breast implant placement at the site of intended expansion.
+2 more criteria

Locations (5)

Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua

Rancagua, Chile

Centro Europeo de Cirugia

San José, Provincia de San José, Costa Rica

The Panama Clinic Complejo Hospitalario Pacific Center

Panama City, Panama

Centro de Patología de la Mama

Madrid, Spain

Hospital Gregorio Marañón

Madrid, Spain

Key Dates

Start Date

December 14, 2020

Primary Completion Date

December 15, 2024

Completion Date

July 15, 2026

Last Updated

August 27, 2024

Enrollment

136

ESTIMATED participants

Conditions

Breast Tissue AccessoryBreast Cancer

Interventions

Breast Tissue Expander

DEVICE

Contacts

Catalina Solano

CONTACT

+506-83112829 csolano@establishmentlabs.com

Jorge Villalobos

CONTACT

+506-8839 6446 jvillalobosa@establishmentlabs.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Motiva Flora Tissue Expander PMCF

Inclusion Criteria

Exclusion Criteria

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