An interventional study of Breast Tissue Expander in Breast Tissue Accessory and Breast Cancer, sponsored by Establishment Labs. Recruiting at 5 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Establishment Labs · Not applicable, Interventional, and Treatment
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 136 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Establishment Labs is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For substudy - MRI / CT - the following additional criteria apply:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
136 participants will undergo two-stage reconstruction
Device: Breast Tissue Expander
tissue expander based breast reconstruction
Also known as: Motiva Flora Tissue Expander
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-up
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-up
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-up
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-up
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 explantation
MRI and potential incidents
Incidents attributable to MR exposure.
Time frame: Up to 6 months follow-up
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-up
Device interference on MRI
Device interference on MRI measured through artifact size
Time frame: Up to 6 months follow-up
In vivo testing of device interference with CT radiotherapy planning.
Radiological Report after undergo CT: - Interference with CT.
Time frame: Up to 6 months follow-up
Plan to share: Undecided
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Establishment Labs