Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation
Recruiting
N/A
Interventional Study
Device Safety
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 120 (estimated)
- Sponsor
- Establishment Labs · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 estimatin…
Contacts