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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Tissue Accessory
• Intervention / Treatment: Device: Breast Tissue Expander

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catalina Solano; Phone Number: +506-83112829; Email: csolano@establishmentlabs.com
• Study Contact Backup: Name: Jorge Villalobos; Phone Number: +506-8839 6446; Email: jvillalobosa@establishmentlabs.com

Study Locations

• Chile
  • Rancagua, Chile
    • Recruiting
    • Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
    • Contact: Viviana Sprohnle, MD
    • Principal Investigator: Viviana Sprohnle, MD
• Costa Rica
  • San Jose
    • San José, San Jose, Costa Rica
      • Recruiting
      • Centro Europeo de Cirugía
      • Contact: Catalina Solano; Phone Number: 83112829; Email: csolano@establishmentlabs.com
      • Contact: Jorge Villalobos; Phone Number: +506-88396446; Email: jvillalobosa@establishmentlabs.com
      • Principal Investigator: Allan Ramos Esquivel
• Panama
  • Panama, Panama
    • Recruiting
    • The Panama Clinic Complejo Hospitalario Pacific Center
    • Contact: Catalina Solano; Phone Number: +506-83112829; Email: csolano@establishmentlabs.com
    • Contact: Luis Picard-Ami; Phone Number: +507-67479911; Email: lpicardami@gmail.com
    • Principal Investigator: Luis Picard-Ami
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Gregorio Marañon
    • Contact: Jose Maria Lasso, MD
    • Principal Investigator: Jose Maria Lasso, MD
  • Madrid, Spain
    • Recruiting
    • Centro de Patología de la Mama
    • Contact: Antonio Tejerina, MD
    • Principal Investigator: Antonio Tejerina, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• Participant willing to undergo an MRI, CT scan and any other studies if required at surgeon discretion.

For substudy - MRI / CT - the following additional criteria apply:

- Patient is willing to undergo one MRI and one CT anytime during the follow up

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.
• Participant with a history of silicone sensitivity.
• Employees of Establishment Labs or any of its divisions or sites; Researchers or anyone who collaborates on the study or is directly related to a person working for Establishment Labs, sites or commissioned Researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Two-stage reconstruction; 136 participants will undergo two-stage reconstruction	Device: Breast Tissue Expander; tissue expander based breast reconstruction; Other Names: Motiva Flora Tissue Expander

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the device and procedure-related adverse events	Cumulative incidence of the device and procedure-related adverse events as assessed by occurrence, seriousness, severity, causal relationship with the device	6 months follow-up
Perceived success of breast tissue expansion	Success of the process as perceived by the investigator considering change in final breast volume and comparison with expected volume	6 months follow-up
Expected completion of breast tissue expansion	Evaluate the time it took to reach the desired expansion following planning.	Up to 6 months follow-up
Satisfaction assessed by the 5 point Likert scale	- Surgeon's overall satisfaction (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) at each follow-up visit.	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrity of the fixing tabs defined as tabs being intact at explantation	Observation of Integrity of the fixing tabs defined as tabs being intact at explanation with no detachments and cuts.	During the intervention/procedure/surgery for explantation
MRI and potential incidents	Incidents attributable to MR exposure.	Up to 6 months follow-up
MRI and port locator performance measured through accurate locator function	Motiva Flora® Port locator performance after MRI measured through accurate location defined when the green light on the device comes on	Up to 6 months follow-up
Device interference on MRI	Device interference on MRI measured through artifact size	Up to 6 months follow-up
In vivo testing of device interference with CT radiotherapy planning.	Radiological Report after undergo CT: - Interference with CT.	Up to 6 months follow-up

Collaborators and Investigators

• Sponsor: Establishment Labs

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CLINP-001001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No