Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
NCT ID: NCT07135011
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-04-12
2026-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Safety and performance of medical devices
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.
Primary gluteal enhancement
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.
Interventions
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Primary gluteal enhancement
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Establishment Labs
INDUSTRY
Responsible Party
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Principal Investigators
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Adolfo Ortiz Barboza, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Establishment Labs
Alajuela, Provincia de San José, Costa Rica
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLINP-01017
Identifier Type: -
Identifier Source: org_study_id
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