Breast Tissue AccessoryNCT05447988
Motiva Flora Tissue Expander PMCF
A study testing Breast Tissue Expander in people with Breast Tissue Accessory and Breast Cancer, run by Establishment Labs at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Tissue Accessory, Breast Cancer
- What is being tested?
- Breast Tissue Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 14 Dec 2020to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Spain2 sites, 2 recruiting
- Recruiting
Centro de Patología de la Mama
Madrid
Antonio Tejerina, MD
Antonio Tejerina, MD
- Recruiting
Hospital Gregorio Marañón
Madrid
Jose Maria Lasso, MD
Jose Maria Lasso, MD
Chile1 site, 1 recruiting
- Recruiting
Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
Rancagua
Viviana Sprohnle, MD
Viviana Sprohnle, MD
Costa Rica1 site, 1 recruiting
- Recruiting
Centro Europeo de Cirugia
San José, Provincia de San José
Catalina Solano, 83112829, csolano@establishmentlabs.com
Jorge Villalobos, +506-88396446, jvillalobosa@establishmentlabs.com
Panama1 site, 1 recruiting
- Recruiting
The Panama Clinic Complejo Hospitalario Pacific Center
Panama City
Catalina Solano, +506-83112829, csolano@establishmentlabs.com
Luis Picard-Ami, +507-67479911, lpicardami@gmail.com
About this study
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
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
- Being tested
- Breast Tissue Expander
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Tissue ExpanderDevice
Also called Motiva Flora Tissue Expander
tissue expander based breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Two-stage reconstruction | Other | 136 participants will undergo two-stage reconstruction Receives: Device: Breast Tissue Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months follow-up
Expected completion of breast tissue expansion
Evaluate the time it took to reach the desired expansion following planning.
Measured: 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.
Measured: 6 months follow-up
Secondary outcomes (5)
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.
Measured: During the intervention/procedure/surgery for explantation
MRI and potential incidents
Incidents attributable to MR exposure.
Measured: 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
Measured: Up to 6 months follow-up
Device interference on MRI
Device interference on MRI measured through artifact size
Measured: Up to 6 months follow-up
In vivo testing of device interference with CT radiotherapy planning.
Radiological Report after undergo CT:
- Interference with CT.
Measured: Up to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start14 Dec 2020
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Tissue AccessoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Establishment Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447988
- Sponsor's protocol ID
- CLINP-001001
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05447988
- Acronym / sponsor ID
- CLINP-001001
- Conditions
- Breast Tissue Accessory, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two-stage reconstruction | Other | Device: Breast Tissue Expander136 participants will undergo two-stage reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Tissue ExpanderAlso: Motiva Flora Tissue Expandertissue expander based breast reconstruction | Device | Two-stage reconstruction |
Primary outcome
Incidence of the device and procedure-related adverse events
Time frame: 6 months follow-up
Cumulative incidence of the device and procedure-related adverse events as assessed by occurrence, seriousness, severity, causal relationship with the device
Perceived success of breast tissue expansion
Time frame: 6 months follow-up
Success of the process as perceived by the investigator considering change in final breast volume and comparison with expected volume
Expected completion of breast tissue expansion
Time frame: Up to 6 months follow-up
Evaluate the time it took to reach the desired expansion following planning.
Satisfaction assessed by the 5 point Likert scale
Time frame: 6 months follow-up
- Surgeon's overall satisfaction (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) at each follow-up visit.
5 secondary outcomes
Integrity of the fixing tabs defined as tabs being intact at explantation
Time frame: During the intervention/procedure/surgery for explantation
MRI and potential incidents
Time frame: Up to 6 months follow-up
MRI and port locator performance measured through accurate locator function
Time frame: Up to 6 months follow-up
Device interference on MRI
Time frame: Up to 6 months follow-up
In vivo testing of device interference with CT radiotherapy planning.
Time frame: Up to 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Tissue Expander in people with Breast Tissue Accessory and Breast Cancer, run by Establishment Labs at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Chile, Costa Rica, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catalina Solano (+506-83112829, csolano@establishmentlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the device and procedure-related adverse events (time frame: 6 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.