Motiva Flora Tissue Expander PMCF

NCT05447988 | Recruiting

• 1 other identifier: CLINP-001001
• Study Type: interventional
• Target: 136
• Locations: 4 countries
• Sites: 5

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.

Conditions

Breast Tissue Accessory; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Expected completion of breast tissue expansion

  Evaluate the time it took to reach the desired expansion following planning.

  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.

  6 months follow-up

Secondary Outcomes (5)

• Integrity of the fixing tabs defined as tabs being intact at explantation

  During the intervention/procedure/surgery for explantation

• MRI and potential incidents

  Up to 6 months follow-up

• MRI and port locator performance measured through accurate locator function

  Up to 6 months follow-up

• Device interference on MRI

  Up to 6 months follow-up

• In vivo testing of device interference with CT radiotherapy planning.

  Up to 6 months follow-up

Study Arms (1)

Two-stage reconstruction

OTHER

136 participants will undergo two-stage reconstruction

Device: Breast Tissue Expander

Interventions

Breast Tissue Expander DEVICE

tissue expander based breast reconstruction

Also known as: Motiva Flora Tissue Expander

Two-stage reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Establishment Labs: lead

Study Sites (5)

Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua

Rancagua, Chile

RECRUITING

Centro Europeo de Cirugia

San José, Provincia de San José, Costa Rica

RECRUITING

The Panama Clinic Complejo Hospitalario Pacific Center

Panama City, Panama

RECRUITING

Centro de Patología de la Mama

Madrid, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, Spain

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tissue Expansion Devices

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Catalina Solano

CONTACT

+506-83112829; csolano@establishmentlabs.com

Jorge Villalobos

CONTACT

+506-8839 6446; jvillalobosa@establishmentlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 7, 2022
• Study Start: December 14, 2020
• Primary Completion: December 15, 2024
• Study Completion (Estimated): July 15, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CL (1); CO (1); ES (2); PA (1)