Device SafetyGEMNCT07135011
Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
A study testing Primary gluteal enhancement in people with Device Safety, run by Establishment Labs at 1 site in Costa Rica.
Trial summary
The objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure, involving 120… 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
- Device Safety
- What is being tested?
- Primary gluteal enhancement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCosta Rica
- Study dates
- 12 Apr 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Cisgender women, aged 18 years or older.
- Participants without prior buttock augmentation or biopolymer injections in the buttocks.
- Participants classified as ASA class I and II according to the American Society of Anesthesiologists (ASA) classification system for estimating risk.
- Participants seeking buttock enhancement, aiming to simply restore the aesthetic curvature of the back.
- Body mass index between 18.5 and 28.
- Adequate tissue available to cover the implant(s).
- Willingness to comply with all study requirements and agree to attend all required follow-up visits.
- Agreement to return the device to the sponsor in case of explantation.
Who cannot join
- Women with massive weight loss.
- Buttock ptosis or poor skin quality.
- Inadequate tissue (e.g., due to radiation damage, ulceration, compromised vascularization, history of compromised healing).
- Current pregnancy.
- History of abscesses or infections in the buttock area.
- History of sensitivity to silicone.
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- Any medical condition such as underweight or obesity according to inclusion criteria, diabetes, autoimmune disease, or severe chronic pulmonary or cardiovascular disease resulting in excessively high surgical risk and significant postoperative complications.
- History of psychological characteristics that are unrealistic or unreasonable given the risks associated with the surgical procedure.
- Use of any medication that, according to the investigator's experience, may pose a higher risk of complications or interfere with wound healing capacity, such as corticosteroid treatment or blood-thinning medications (e.g., concomitant treatment with warfarin).
- Participants who do not reside in the Great Metropolitan Area of Costa Rica, which makes it difficult for them to attend follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Costa Rica1 site, 1 recruiting
- Recruiting
Establishment Labs
Alajuela, Provincia de San José, 20101
Jorge Villalobos Alpizar, MD, +506 8839-6446, jvillalobosa@establishmentlabs.com
Laura Garcia Jimenez, +506 8997-2767, lgarcia@establishmentlabs.com
About this study
Official title: Adaptive Study to Assess the Initial Safety and Functioning of the Minimally Invasive Gluteal Augmentation Procedure and Its Devices in Participants Undergoing Primary Gluteal Enhancement
The objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure, involving 120 healthy female participants.
The main questions it aims to answer are:
- Are the main side effects and complications experienced by participants who underwent a minimally invasive buttock enhancement procedure with Motiva Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator adequately characterized?
- Can the Motiva Injector®, Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator be successfully utilized, and are any failures in the process detected?
- Does the Motiva® GEM Channel Separator effectively perform tissue dissection procedures without experiencing operational dysfunctions?
- Are both the surgeon and the participant satisfied with the procedure outcomes?
- Is the proper functioning of the Zen microtransponder verified? Participants will undergo a minimally invasive buttock enhancement procedure using the Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator, and have a follow-up of 24 months to see the results.
Read the detailed description
This is a prospective, open-label, interventional study lasting 24 months, aimed at evaluating the safety and performance of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure.
The devices included in this study are indicated for use in the chest area. According to an ongoing study, their safety and performance have been demonstrated. It is not expected that the off-label use of Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator in the gluteal area will increase any risks or potential harm to the participants. On the contrary, the minimally invasive procedure is expected to provide more positive and safer outcomes.
This study has been designed as an adaptive study since the devices to be used are not indicated for use in the gluteal area. This allows for careful evaluation of real-time clinical data to make decisions regarding clinical development. This study will consist of two stages: the feasibility stage and the pivotal stage.
It involves the decision to progress participant recruitment from the feasibility phase to the pivotal phase, as long as there are no unknown complications, serious incidents, or incidents not previously described in available literature. A pre-planned interim analysis will be conducted every 6 months. It will analyze enrolled participants, their complications, and satisfaction. The collected data will be considered to decide transition stages.
The scope of the adaptive design is to combine these two stages of clinical development to:
- Maximize trial information
- Shorten development timelines
- Reduce risk for study participants and the sponsor
- Regulatory advantages
For this study, 120 women will be recruited according to the study's requirements from different countries in Latin America to undergo a minimally invasive gluteal enhancement procedure using Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator. The study period will last up to 24 months, and recruitment is expected to last up to six months.
- Conditions
- Device Safety
- Being tested
- Primary gluteal enhancement
- Keywords
- Equipment safety, Buttock augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary gluteal enhancementDevice
120 participants will undergo primary buttock enhancement procedures utilizing the Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator devices.
| Study group | Role | What they receive |
|---|---|---|
| Safety and performance of medical devices | Experimental | 120 participants will undergo primary gluteal enhancement procedures utilizing the Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator devices. Receives: Device: Primary gluteal enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety e:valuation
Safety will be assessed through the cumulative incidence (number of cases) of adverse events during surgery and the follow-up period. The severity and duration of all complications (rate of procedure-related adverse events/device-related adverse events) will be included. Safety will be evaluated through a survival analysis.
Measured: 24 months
Primary Performance Evaluation
The performance of the devices will be evaluated as successful in all cases of buttock enhancement where there is no device malfunction. All assessment criteria must be analyzed per participant and per buttock. A 90% confidence interval will be obtained for each parameter when applied.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start12 Apr 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device SafetyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, adaptive, interventional study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Establishment Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adolfo Ortiz Barboza, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135011
- Sponsor's protocol ID
- CLINP-01017
- Acronym
- GEM
- Status last verified
- Aug 2025
- First submitted
- 2 Dec 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Study to Assess the Initial Safety and Functioning of the Minimally Invasive Gluteal Augmentation Procedure and Its Devices in Participants Undergoing Primary Gluteal Enhancement
- ClinicalTrials.gov ID
- NCT07135011
- Acronym / sponsor ID
- GEM / CLINP-01017
- Conditions
- Device Safety
- Keywords
- Equipment safety, Buttock augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Aug 2025 (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 objective of this clinical trial is to assess the initial performance and safety of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure, involving 120 healthy female participants.
The main questions it aims to answer are:
- Are the main side effects and complications experienced by participants who underwent a minimally invasive buttock enhancement procedure with Motiva Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator adequately characterized?
- Can the Motiva Injector®, Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator be successfully utilized, and are any failures in the process detected?
- Does the Motiva® GEM Channel Separator effectively perform tissue dissection procedures without experiencing operational dysfunctions?
- Are both the surgeon and the participant satisfied with the procedure outcomes?
- Is the proper functioning of the Zen microtransponder verified? Participants will undergo a minimally invasive buttock enhancement procedure using the Ergonomix2® Diamond®, the Motiva Injector®, the Motiva® Inflatable Balloon, the Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator, and have a follow-up of 24 months to see the results.
Detailed description
This is a prospective, open-label, interventional study lasting 24 months, aimed at evaluating the safety and performance of Motiva® Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator utilized in a minimally invasive gluteal augmentation procedure.
The devices included in this study are indicated for use in the chest area. According to an ongoing study, their safety and performance have been demonstrated. It is not expected that the off-label use of Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator in the gluteal area will increase any risks or potential harm to the participants. On the contrary, the minimally invasive procedure is expected to provide more positive and safer outcomes.
This study has been designed as an adaptive study since the devices to be used are not indicated for use in the gluteal area. This allows for careful evaluation of real-time clinical data to make decisions regarding clinical development. This study will consist of two stages: the feasibility stage and the pivotal stage.
It involves the decision to progress participant recruitment from the feasibility phase to the pivotal phase, as long as there are no unknown complications, serious incidents, or incidents not previously described in available literature. A pre-planned interim analysis will be conducted every 6 months. It will analyze enrolled participants, their complications, and satisfaction. The collected data will be considered to decide transition stages.
The scope of the adaptive design is to combine these two stages of clinical development to:
- Maximize trial information
- Shorten development timelines
- Reduce risk for study participants and the sponsor
- Regulatory advantages
For this study, 120 women will be recruited according to the study's requirements from different countries in Latin America to undergo a minimally invasive gluteal enhancement procedure using Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator. The study period will last up to 24 months, and recruitment is expected to last up to six months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, adaptive, interventional study
| Arm | Type | Receives |
|---|---|---|
| Safety and performance of medical devices | Experimental | Device: Primary gluteal enhancement120 participants will undergo primary gluteal enhancement procedures utilizing the Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cisgender women, aged 18 years or older.
- Participants without prior buttock augmentation or biopolymer injections in the buttocks.
- Participants classified as ASA class I and II according to the American Society of Anesthesiologists (ASA) classification system for estimating risk.
- Participants seeking buttock enhancement, aiming to simply restore the aesthetic curvature of the back.
- Body mass index between 18.5 and 28.
Key exclusion criteria (10 listed)
- Women with massive weight loss.
- Buttock ptosis or poor skin quality.
- Inadequate tissue (e.g., due to radiation damage, ulceration, compromised vascularization, history of compromised healing).
- Current pregnancy.
- History of abscesses or infections in the buttock area.
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 |
|---|---|---|
| Primary gluteal enhancement120 participants will undergo primary buttock enhancement procedures utilizing the Ergonomix2® Diamond®, Motiva Injector®, Motiva® Inflatable Balloon, Motiva® Reusable Channel Dissector, and Motiva® GEM Channel Separator devices. | Device | Safety and performance of medical devices |
Primary outcome
Primary Safety e:valuation
Time frame: 24 months
Safety will be assessed through the cumulative incidence (number of cases) of adverse events during surgery and the follow-up period. The severity and duration of all complications (rate of procedure-related adverse events/device-related adverse events) will be included. Safety will be evaluated through a survival analysis.
Primary Performance Evaluation
Time frame: 24 months
The performance of the devices will be evaluated as successful in all cases of buttock enhancement where there is no device malfunction. All assessment criteria must be analyzed per participant and per buttock. A 90% confidence interval will be obtained for each parameter when applied.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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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.
Adolfo Ortiz Barboza, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary gluteal enhancement in people with Device Safety, 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Villalobos Alpizar, MD (+506 8839-6446, jvillalobosa@establishmentlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety e:valuation (time frame: 24 months). 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 21 Aug 2025.