Breast Implant; ComplicationsNCT06274736
Safety and Performance of Motiva® Sizers
An observational study of Breast Implant; Complications and Breast Implantation; Methods, Safety and Performance, run by Establishment Labs at 1 site in Costa Rica.
Trial summary
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures. The research will include 133 women, divided into two groups (56 with sizers and 78 without sizers). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty
- What is being tested?
- Motiva Sizer
- Type of treatment
- Medical device
- How many people
- 133 participants
- Where
- 1 siteCosta Rica
- Study dates
- 10 Apr 2023to 21 Jan 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women over 18 years of age who will undergo breast augmentation or reconstruction. They will be divided into two groups: * Group exposed to Motiva® Sizer: 56 participants (51 breast augmentation participants and 5 reconstruction participants). * Group not exposed to Motiva® Sizer: 78 participants (74 breast augmentation participants and 4 reconstruction participants).
Who may be able to join
- Female, 18 years of age or older.
- The participant will be undergoing a breast augmentation or reconstruction procedure.
- To possess enough and adequate tissue to cover the implants.
- Willingness to comply with all study requirements, including signing the informed consent document and agreeing to attend all required follow-up visits.
Who cannot join
- Existing rib injuries.
- Inadequate or unsuitable tissue for augmentation or reconstruction surgery at the physician's discretion.
- History of abscesses or infections in the breast area.
- Current pregnancy or breastfeeding, or full-term pregnancy or breastfeeding in the six months prior to enrollment.
- History of sensitivity to silicone.
- Any medical condition, such as underweight or obesity, diabetes, autoimmune disease or severe chronic pulmonary or cardiovascular disease, psychological/psychiatric disorders that may result in unduly high surgical risk and/or significant postoperative complications.
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- Active or recurrent breast cancer.
- Consumption of any medication that, in the investigator's experience, may pose an increased risk of complications or interfere with wound healing ability, such as corticosteroid therapy or blood clotting medication (e.g., concomitant treatment with warfarin).
- Not living in the country where the procedure was performed , which prevents him/her from attending follow-up visits .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Cohort Study to Confirm the Safety and Performance of Motiva® Sizers in Breast Augmentation and Reconstruction Procedures
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
The research will include 133 women, divided into two groups (56 with sizers and 78 without sizers). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.
Read more
The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.
After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5) one year. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction, Breast Augmentation
- Being tested
- Motiva Sizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motiva SizerDevice
No intervention will be made,
| Study group | Role | What they receive |
|---|---|---|
| Women who will undergo a breast augmentation or reconstruction with Motiva® Sizer during surgery. | Not described Receives: Device: Motiva Sizer | |
| Women who will undergo a breast augmentation or reconstruction without Motiva® Sizer during surgery. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motiva Sizers Safety (complications)
Cumulative incidence of complications between participants in whom Motiva® Sizer was used during breast augmentation or reconstruction surgery, and participants in whom intraoperative breast sizers were not used during breast augmentation or reconstruction surgery
Measured: 1 year
Motiva Sizers Performance (satisfaction)
Percentage of participants and surgeons who are satisfied or very satisfied with surgery´s results with and without Motiva® Sizer. (based on 5-point Likert scale, in which 1 is Very dissatisfied, 2 Dissatisfied, 3 Neither satisfied nor dissatisfied, 4 Satisfied, 5 Very satisfied) measured at 1st, 3rd, 6th months after surgery and 1st year.
Measured: 1 year
Secondary outcomes (1)
Motiva Sizers Safety (reoperations)
Re-operation rates between participants in whom Motiva® Sizers were used during augmentation or breast reconstruction surgery and participants in whom Motiva® Sizers were not used during augmentation or breast reconstruction surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Apr 2023
- Primary completion10 Dec 2023
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 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
- NCT06274736
- Sponsor's protocol ID
- CLINP-001012
- Status last verified
- May 2026
- First submitted
- 27 Dec 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Cohort Study to Confirm the Safety and Performance of Motiva® Sizers in Breast Augmentation and Reconstruction Procedures
- ClinicalTrials.gov ID
- NCT06274736
- Acronym / sponsor ID
- CLINP-001012
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction, Breast Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 23 Feb 2024 (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® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
The research will include 133 women, divided into two groups (56 with sizers and 78 without sizers). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.
The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.
After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5) one year. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women who will undergo a breast augmentation or reconstruction with Motiva® Sizer during surgery. | – | Device: Motiva Sizer |
| Women who will undergo a breast augmentation or reconstruction without Motiva® Sizer during surgery. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years of age who will undergo breast augmentation or reconstruction. They will be divided into two groups: * Group exposed to Motiva® Sizer: 56 participants (51 breast augmentation participants and 5 reconstruction participants). * Group not exposed to Motiva® Sizer: 78 participants (74 breast augmentation participants and 4 reconstruction participants).
Key inclusion criteria (4 listed)
- Female, 18 years of age or older.
- The participant will be undergoing a breast augmentation or reconstruction procedure.
- To possess enough and adequate tissue to cover the implants.
- Willingness to comply with all study requirements, including signing the informed consent document and agreeing to attend all required follow-up visits.
Key exclusion criteria (9 listed)
- Existing rib injuries.
- Inadequate or unsuitable tissue for augmentation or reconstruction surgery at the physician's discretion.
- History of abscesses or infections in the breast area.
- Current pregnancy or breastfeeding, or full-term pregnancy or breastfeeding in the six months prior to enrollment.
- History of sensitivity to silicone.
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 SizerNo intervention will be made, | Device | Women who will undergo a breast augmentation or reconstruction with Motiva® Sizer during surgery. |
Primary outcome
Motiva Sizers Safety (complications)
Time frame: 1 year
Cumulative incidence of complications between participants in whom Motiva® Sizer was used during breast augmentation or reconstruction surgery, and participants in whom intraoperative breast sizers were not used during breast augmentation or reconstruction surgery
Motiva Sizers Performance (satisfaction)
Time frame: 1 year
Percentage of participants and surgeons who are satisfied or very satisfied with surgery´s results with and without Motiva® Sizer. (based on 5-point Likert scale, in which 1 is Very dissatisfied, 2 Dissatisfied, 3 Neither satisfied nor dissatisfied, 4 Satisfied, 5 Very satisfied) measured at 1st, 3rd, 6th months after surgery and 1st year.
1 secondary outcome
Motiva Sizers Safety (reoperations)
Time frame: 1 year
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 2 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications and Breast Implantation; Methods, Safety and Performance, run by Establishment Labs at 1 site in Costa Rica.
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 4 inclusion and 9 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Costa Rica. 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?
Motiva Sizers Safety (complications) (time frame: 1 year). The study lists 2 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 2 Jun 2026.