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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Motiva Flora TE

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Dr Filip Stillaert
• Spain
  • Madrid, Spain
    • Fundacion Tejerina

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The patient has had a complete tissue-expander based breast reconstruction with the Motiva Flora® TE .

Description

Inclusion Criteria:

• Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
• Patient has been informed correctly according to to the applicable national and local regulations.

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - adverse events	Cumulative incidence and causal relationship with the device of adverse events (AEs) reported by the surgeon. This includes known complications as listed in the IFU, as well as any other adverse events, seen as at least possibly related to the device according to the surgeon.	Until finalization of staged Breast reconstruction, approximately 6 months
Safety - device deficiencies	Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.	Until finalization of staged Breast reconstruction, approximately 6 months
Performance - succesful implant of long-term breast implant	Successful tissue expander-based-breast reconstruction is measured by the fact that the second step of the staged procedure - the implantation of the long-term breast implant - could be performed or not as initially planned, as per surgeon judgement (Yes / No)	Until finalization of staged Breast reconstruction, approximately 6 months
Performance - surgeon satisfaction	Surgeon's overall satisfaction with the results of the expansion according to the General Aesthetic Improvement Scale (GAIS), a 5-point Likert scale (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) after the completion of the breast reconstruction (after the second surgery (long-term breast implant).	Until finalization of staged Breast reconstruction, approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospitalization	Length of hospitalization is measured in number of days that the patient stays in hospital after surgery, starting from the day after surgery.	Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days
Surgical difficulties- 1st surgery (Motiva Flora TE implantation)	Possible difficulties during the during the 1st surgery, measured through the occurrence of: device deficiencies / malfunctions; difficulties filling the Tissue expander with the Port Locator	Intraoperative
Surgical difficulties - 2nd surgery (Long-term breast implant)	Possible difficulties during the 2nd surgery, measured through the occurrence of: o device deficiencies /malfunctions	Intraoperative
Concomitant treatments - 1st surgery	Concomitant treatments during the 1st surgery is measured through the occurrence of: Lipotransfer; Latissimus Dorsi Flap	Intraoperative
Concomitant treatments - 2nd surgery	Concomitant treatments during the 2nd surgery is measured through the: Use of Motiva Sizers; The occurrence of Lipotransfer	Intraoperative

Collaborators and Investigators

• Sponsor: Establishment Labs

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 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-001013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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