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Completed

NCT Number: NCT05459064

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dr Filip Stillaert, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motiva Flora TE

Device

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.

Primary outcomes

  1. Safety - adverse events

    Time frame: 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.

  2. Safety - device deficiencies

    Time frame: 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.

  3. Performance - succesful implant of long-term breast implant

    Time frame: 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)

  4. Performance - surgeon satisfaction

    Time frame: 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 outcomes

  1. Length of hospitalization

    Time frame: 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.

  2. Surgical difficulties- 1st surgery (Motiva Flora TE implantation)

    Time frame: 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

  3. Surgical difficulties - 2nd surgery (Long-term breast implant)

    Time frame: Intraoperative

    Possible difficulties during the 2nd surgery, measured through the occurrence of:

    o device deficiencies /malfunctions

  4. Concomitant treatments - 1st surgery

    Time frame: Intraoperative

    Concomitant treatments during the 1st surgery is measured through the occurrence of:

    • Lipotransfer
    • Latissimus Dorsi Flap

  5. Concomitant treatments - 2nd surgery

    Time frame: Intraoperative

    Concomitant treatments during the 2nd surgery is measured through the:

    • Use of Motiva Sizers
    • The occurrence of Lipotransfer

Sponsors and collaborators

Lead sponsor

Establishment Labs

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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