Adaptive Study to Assess the Safety and Functioning of Motiva Devices on Minimally Invasive Gluteal Augmentation

NCT07135011 | Recruiting DMC

• 1 other identifier: CLINP-01017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Device Safety

Keywords

Equipment safety; Buttock augmentation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Study Arms (1)

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.

Device: Primary gluteal enhancement

Interventions

Primary gluteal enhancement DEVICE

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.

Safety and performance of medical devices

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Establishment Labs: lead

Study Sites (1)

Establishment Labs

Alajuela, Provincia de San José, 20101, Costa Rica

RECRUITING

Study Officials

• Adolfo Ortiz Barboza, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Villalobos Alpizar, MD

CONTACT

+506 8839-6446; jvillalobosa@establishmentlabs.com

Laura Garcia Jimenez

CONTACT

+506 8997-2767; lgarcia@establishmentlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, adaptive, interventional study

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: August 21, 2025
• Study Start: April 12, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CO (1)