Clinical trial NCT05447988: Motiva Flora Tissue Expander PMCF
Official title: Post-Marketing Clinical Follow-Up Study to Confirm the Safety and Effectiveness/Performance of Motiva Flora® Tissue Expander in Staged Breast Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Tissue Accessory
Breast Cancer
Lead sponsor: Establishment Labs
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria

* 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.
* The participant has the physical and cognitive capacity to understand and follow the surgeon's recommendations.
* Complete radiotherapy at least 1 year before surgery.
* Partial or total decrease in tumour volume after radiotherapy.
* The participant is able and willing to comply with all study requirements including attending follow-up appointments.
* Participant with reasonable surgical risk.
* Participant with a history of non-metastatic breast cancer.
* Participant willing to undergo an MRI, CT scan and any other studies if required at surgeon discretion.

For substudy - MRI / CT - the following additional criteria apply:

- Patient is willing to undergo one MRI and one CT anytime during the follow up

Exclusion Criteria:

* 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.
* 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 scar deformity.
* Participants with current or previous infection in the area where the expansion will take place.
* Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
* Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts or radical resection of the pectoralis major muscle.
* Participant who is included in another pharmacological or device research study.
* Participants with a previous history of failure of attempted tissue expansion or breast implant placement at the site of intended expansion.
* Participant with a history of silicone sensitivity.
* Employees of Establishment Labs or any of its divisions or sites; Researchers or anyone who collaborates on the study or is directly related to a person working for Establishment Labs, sites or commissioned Researchers.

Primary outcomes:
measure: Incidence of the device and procedure-related adverse events
timeFrame: 6 months follow-up
measure: Perceived success of breast tissue expansion
timeFrame: 6 months follow-up
measure: Expected completion of breast tissue expansion
timeFrame: Up to 6 months follow-up
measure: Satisfaction assessed by the 5 point Likert scale
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Integrity of the fixing tabs defined as tabs being intact at explantation
timeFrame: During the intervention/procedure/surgery for explantation
measure: MRI and potential incidents
timeFrame: Up to 6 months follow-up
measure: MRI and port locator performance measured through accurate locator function
timeFrame: Up to 6 months follow-up
measure: Device interference on MRI
timeFrame: Up to 6 months follow-up
measure: In vivo testing of device interference with CT radiotherapy planning.
timeFrame: Up to 6 months follow-up
Other outcomes:
Locations:
city: Rancagua
country: Chile
facility: Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
city: San José
country: Costa Rica
facility: Centro Europeo de Cirugia
state: San Jose
city: Panama
country: Panama
facility: The Panama Clinic Complejo Hospitalario Pacific Center
city: Madrid
country: Spain
facility: Centro de Patología de la Mama
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
Study officials:
References: