Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
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
Establishment Labs
120 participants
Apr 12, 2023
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria11
- 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.
- 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 Criteria6
- 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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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07135011