Motiva Flora® Aesthetic Breast Recon® Clinical Study

November 29, 2023 updated by: Establishment Labs

Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study

The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
        • Contact:
        • Principal Investigator:
          • Filip Stillaert, PhD. MD.
  • Colombia
      • Bogotá, Colombia
        • Not yet recruiting
        • Hospital Universitario San Ignacio
        • Contact:
        • Principal Investigator:
          • Juan Carlos Zambrano-Bürgl, MD
  • Costa Rica
      • San José, Costa Rica
        • Not yet recruiting
        • Hospital UNIBE
        • Contact:
        • Sub-Investigator:
          • Francisco Vargas Villalobos, MD
        • Sub-Investigator:
          • Alfredo Vargas Villalobos, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Jaume Masià Ayala, MD
        • Sub-Investigator:
          • Silvia Condrea, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Genetically female, aged 18 years or older.
  2. Subjects who had provided written informed consent form.
  3. The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.
  4. Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.
  5. Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.
  6. Complete radiotherapy and chemotherapy at least one year before surgery.
  7. BMI between 18.5 and 30.0 (average classified weight).
  8. Physical and cognitive capacity to understand and follow the surgeon's recommendations.

  9. To be able and willing to comply with all study requirements, including attending follow-up appointments.

    Only Sub study participants

  10. Provide additional consent to undergo an MRI with contrast.

Exclusion Criteria:

  1. Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.
  2. Abnormal hematological and biochemical values after chemotherapy.
  3. High surgical risk according to the investigator.
  4. Breast width larger than 18 cm
  5. Tumor residues in or near the area where tissue expansion is performed.
  6. Subjects with metastatic breast cancer
  7. Significant Breast ptosis or poor skin quality
  8. 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 mastectomy scar deformity.
  9. Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.
  10. Current or previous infection in the area where the expansion occurs.
  11. Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.
  12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
  13. History of silicone sensitivity.
  14. Active smokers
  15. Previous attempts of breast reconstruction
  16. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
  17. Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
  18. Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
  19. Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total adverse envent rate
Time Frame: 46 months

This variable will be assessed by the total incidence, seriousness, severity, causal relationship with the device, measure(s) taken for resolution, outcome, and duration of the various adverse events (AEs) reported during the surgery and follow-up period. The incidence of AEs, in terms of percentage, will be evaluated statistically with a 95% confidence interval. The analysis of the AEs will include:

  • All AEs reported during the time period in which Motiva Flora® TE remains implanted (up to a maximum of 16 months)
  • All AEs reported during the conduct of the whole clinical investigation (reconstruction process and 24 months follow-up)
46 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon's overall satisfaction
Time Frame: 46 months
Surgeon's overall satisfaction with reconstruction process and results according to the Global Aesthetic Improvement Scale (GAIS), a 5-point Likert scale: 1) Worse (The appearance is worse than the original condition); 2) No change (The appearance is essentially the same as the original condition); 3) Improved (Obvious improvement in appearance from the initial condition, but a touch-up or retreatment is indicated); 4) Much improved (Marked improvement in appearance from the initial condition, but not completely optimal for this patient. A touch-up would slightly improve the result) and 5) Very much improved (Optimal cosmetic result for the implant in this patient).
46 months
Patient's anxiety and depression
Time Frame: 46 months
Patient's anxiety and depression using the HADS (The Hospital Anxiety Depression Scale)
46 months
Patient's satisfaction and quality of life impact
Time Frame: 46 months
Quality of life and satisfaction levels will be assessed using validated international tool Breast-Q.
46 months
Device's performance: Device integrity
Time Frame: 6-16 months
Percentage of Tissue Expander devices found without any damage at explantation.
6-16 months
Changes in breast volume
Time Frame: 46 months
Percentage of cases where enlargement of the initial breast volume was achieved after the fat grafting process and changes in vascularity of the filled zone documented. after the fat grafting process.
46 months
Changes in breast vascularity
Time Frame: 46 months
Percentage of cases where changes in vascularity of the filled zone were documented after the fat grafting process.
46 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Establishment Labs

Collaborators

NAMSA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-001000

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Motiva Flora® Tissue Expander

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe