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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05459064
• Lead Sponsor: Establishment Labs

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Study Start: 2022-09-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety - adverse events	Until finalization of staged Breast reconstruction, approximately 6 months	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.
Performance - succesful implant of long-term breast implant	Until finalization of staged Breast reconstruction, approximately 6 months	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)
Safety - device deficiencies	Until finalization of staged Breast reconstruction, approximately 6 months	Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.
Performance - surgeon satisfaction	Until finalization of staged Breast reconstruction, approximately 6 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fundacion Tejerina; 🇪🇸 Madrid, Spain

Dr Filip Stillaert; 🇧🇪 Ghent, Belgium