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

NCT05459064 | Completed

• 1 other identifier: CLINP-001013
• Study Type: observational
• Target: 144
• Locations: 2 countries
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Length of hospitalization

  Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days

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

  Intraoperative

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

  Intraoperative

• Concomitant treatments - 1st surgery

  Intraoperative

• Concomitant treatments - 2nd surgery

  Intraoperative

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Establishment Labs: lead

Study Sites (2)

Dr Filip Stillaert

Ghent, Belgium

Location

Fundacion Tejerina

Madrid, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); ES (1)