Motiva Flora Tissue Expander PMCF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEstablishment Labs
About this trial
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery.
The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant gives written informed consent.
The participant is genetically female, aged 18 years or older.
The participant needs tissue expansion as part of breast reconstruction treatment following mastectomy, which may include immediate reconstruction.
The participant is in a suitable clinical condition to allow breast implant placement after tissue expander placement, at the discretion of the investigator.
Disqualifiers
The participant is pregnant or planning a pregnancy during the first year after surgery or is currently breastfeeding.
Participants with implanted devices that may be affected by magnetic fields (pacemakers, drug infusion devices).
Participants with abnormal haematological and biochemical values after chemotherapy.
Participants with tumour residues in or near the area where tissue expansion is to be performed.
Trial design
Design model
Single group
Treatments tested in this trial
Breast Tissue Expander
Devicetissue expander based breast reconstruction
Treatment groups
136 Participants
are divided into 1 treatment groupGroup A: Two-stage reconstructionOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of the device and procedure-related adverse events
Cumulative incidence of the device and procedure-related adverse events as assessed by occurrence, seriousness, severity, causal relationship with the device
Time frame
6 months follow-up2
Perceived success of breast tissue expansion
Success of the process as perceived by the investigator considering change in final breast volume and comparison with expected volume
Time frame
6 months follow-up3
Expected completion of breast tissue expansion
Evaluate the time it took to reach the desired expansion following planning.
Time frame
Up to 6 months follow-up4
Satisfaction assessed by the 5 point Likert scale
\- Surgeon's overall satisfaction (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) at each follow-up visit.
Time frame
6 months follow-upSecondary outcomes
1
Integrity of the fixing tabs defined as tabs being intact at explantation
Observation of Integrity of the fixing tabs defined as tabs being intact at explanation with no detachments and cuts.
Time frame
During the intervention/procedure/surgery for explantation2
MRI and potential incidents
Incidents attributable to MR exposure.
Time frame
Up to 6 months follow-up3
MRI and port locator performance measured through accurate locator function
Motiva Flora® Port locator performance after MRI measured through accurate location defined when the green light on the device comes on
Time frame
Up to 6 months follow-up4
Device interference on MRI
Device interference on MRI measured through artifact size
Time frame
Up to 6 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov