Motiva Flora Tissue Expander PMCF

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447988
• Other study ID #: CLINP-001001
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: July 15, 2026

Study information

• Verified date: November 2023
• Source: Establishment Labs
• Contact: Catalina Solano
• Phone: +506-83112829
• Email: csolano[@]establishmentlabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: July 15, 2026
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Breast Tissue Expander
tissue expander based breast reconstruction

Locations

Country	Name	City	State
Costa Rica	Centro Europeo de Cirugia	San José	San Jose
Panama	Panama Clinic	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Establishment Labs

Countries where clinical trial is conducted

Costa Rica,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months follow-up
Primary	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	6 months follow-up
Primary	Expected completion of breast tissue expansion	Evaluate the time it took to reach the desired expansion following planning.	Up to 6 months follow-up
Primary	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.	6 months follow-up
Secondary	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.	During the intervention/procedure/surgery for explantation
Secondary	MRI and potential incidents	Incidents attributable to MR exposure.	Up to 6 months follow-up
Secondary	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	Up to 6 months follow-up
Secondary	Device interference on MRI	Device interference on MRI measured through artifact size	Up to 6 months follow-up
Secondary	In vivo testing of device interference with CT radiotherapy planning.	Radiological Report after undergo CT: - Interference with CT.	Up to 6 months follow-up

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