Health Trials

Motiva Flora® Aesthetic Breast Recon® Clinical Study

ConditionsMammaplastyBreast CancerPoland Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEstablishment Labs

About this trial

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®.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Genetically female, aged 18 years or older.

Subjects who had provided written informed consent form.

The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.

Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.

Disqualifiers

Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.

Abnormal hematological and biochemical values after chemotherapy.

High surgical risk according to the investigator.

Breast width larger than 18 cm

Trial design

Design model

Single group

Treatments tested in this trial

  • Motiva Flora® Tissue Expander

    Device

    This hybrid breast reconstruction involves a stage in which the tissue expander (Motiva Flora®) is used as intended for a conventional expansion. After achieving the desired volume, it is deflated in a controlled way to proceed with the execution of serial fat grafting procedures (reverse expansion). This also means the expander is implanted longer than indicated on its current Directions For Use. Once the reverse expansion is complete, the expander is replaced with a long-term breast implant. Motiva Implants Ergonomix2® Sterile Silicone Breast Implants will be used as per Standard of Care under the CE marked indication. To obtain the safest, most natural, and aesthetic outcomes, Ergonomix2® breast implants have been selected as the standard silicone breast implants for this study.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Total adverse envent rate

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)

Time frame
46 months

Secondary outcomes

1

Surgeon's overall satisfaction

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).

Time frame
46 months
2

Patient's anxiety and depression

Patient's anxiety and depression using the HADS (The Hospital Anxiety Depression Scale)

Time frame
46 months
3

Patient's satisfaction and quality of life impact

Quality of life and satisfaction levels will be assessed using validated international tool Breast-Q.

Time frame
46 months
4

Device's performance: Device integrity

Percentage of Tissue Expander devices found without any damage at explantation.

Time frame
6-16 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Establishment Labs

Lead sponsor

NAMSA

Collaborator

Source ClinicalTrials.gov
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