Breast CancerNCT05459064
Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
An observational study of Breast Cancer, run by Establishment Labs at 2 sites in 2 countries.
Trial summary
The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Motiva Flora TE
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2022to 30 Jun 2024
- Phase
- Observational
- 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
Study population: The patient has had a complete tissue-expander based breast reconstruction with the Motiva Flora® TE .
Who may be able to join
- Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
- Patient has been informed correctly according to to the applicable national and local regulations.
Who cannot join
- Not applicable
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.
All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.
The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.
- Conditions
- Breast Cancer
- Being tested
- Motiva Flora TE
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motiva Flora TEDevice
This is a retrospective, observational study - collecting data on patients who have gone through the staged procedure with the Motiva Flora Tissue Expander / Long-term breast implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - adverse events
Cumulative incidence and causal relationship with the device of adverse events (AEs) reported by the surgeon. This includes known complications as listed in the IFU, as well as any other adverse events, seen as at least possibly related to the device according to the surgeon.
Measured: Until finalization of staged Breast reconstruction, approximately 6 months
Safety - device deficiencies
Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.
Measured: Until finalization of staged Breast reconstruction, approximately 6 months
Performance - succesful implant of long-term breast implant
Successful tissue expander-based-breast reconstruction is measured by the fact that the second step of the staged procedure - the implantation of the long-term breast implant - could be performed or not as initially planned, as per surgeon judgement (Yes / No)
Measured: Until finalization of staged Breast reconstruction, approximately 6 months
Performance - surgeon satisfaction
Surgeon's overall satisfaction with the results of the expansion according to the General Aesthetic Improvement Scale (GAIS), a 5-point Likert scale (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) after the completion of the breast reconstruction (after the second surgery (long-term breast implant).
Measured: Until finalization of staged Breast reconstruction, approximately 6 months
Secondary outcomes (5)
Length of hospitalization
Length of hospitalization is measured in number of days that the patient stays in hospital after surgery, starting from the day after surgery.
Measured: Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days
Surgical difficulties- 1st surgery (Motiva Flora TE implantation)
Possible difficulties during the during the 1st surgery, measured through the occurrence of:
- device deficiencies / malfunctions
- difficulties filling the Tissue expander with the Port Locator
Measured: Intraoperative
Surgical difficulties - 2nd surgery (Long-term breast implant)
Possible difficulties during the 2nd surgery, measured through the occurrence of:
- device deficiencies /malfunctions
Measured: Intraoperative
Concomitant treatments - 1st surgery
Concomitant treatments during the 1st surgery is measured through the occurrence of:
- Lipotransfer
- Latissimus Dorsi Flap
Measured: Intraoperative
Concomitant treatments - 2nd surgery
Concomitant treatments during the 2nd surgery is measured through the:
- Use of Motiva Sizers
- The occurrence of Lipotransfer
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Establishment Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459064
- Sponsor's protocol ID
- CLINP-001013
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05459064
- Acronym / sponsor ID
- CLINP-001013
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 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® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.
All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.
The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient has had a complete tissue-expander based breast reconstruction with the Motiva Flora® TE .
Key inclusion criteria (2 listed)
- Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .
- Patient has been informed correctly according to to the applicable national and local regulations.
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Motiva Flora TEThis is a retrospective, observational study - collecting data on patients who have gone through the staged procedure with the Motiva Flora Tissue Expander / Long-term breast implant. | Device | – |
Primary outcome
Safety - adverse events
Time frame: Until finalization of staged Breast reconstruction, approximately 6 months
Cumulative incidence and causal relationship with the device of adverse events (AEs) reported by the surgeon. This includes known complications as listed in the IFU, as well as any other adverse events, seen as at least possibly related to the device according to the surgeon.
Safety - device deficiencies
Time frame: Until finalization of staged Breast reconstruction, approximately 6 months
Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.
Performance - succesful implant of long-term breast implant
Time frame: Until finalization of staged Breast reconstruction, approximately 6 months
Successful tissue expander-based-breast reconstruction is measured by the fact that the second step of the staged procedure - the implantation of the long-term breast implant - could be performed or not as initially planned, as per surgeon judgement (Yes / No)
Performance - surgeon satisfaction
Time frame: Until finalization of staged Breast reconstruction, approximately 6 months
Surgeon's overall satisfaction with the results of the expansion according to the General Aesthetic Improvement Scale (GAIS), a 5-point Likert scale (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) after the completion of the breast reconstruction (after the second surgery (long-term breast implant).
5 secondary outcomes
Length of hospitalization
Time frame: Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days
Surgical difficulties- 1st surgery (Motiva Flora TE implantation)
Time frame: Intraoperative
Surgical difficulties - 2nd surgery (Long-term breast implant)
Time frame: Intraoperative
Concomitant treatments - 1st surgery
Time frame: Intraoperative
Concomitant treatments - 2nd surgery
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Establishment Labs at 2 sites in 2 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 2 inclusion and 1 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: finished, 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 2 sites in Belgium, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - adverse events (time frame: Until finalization of staged Breast reconstruction, approximately 6 months). 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.