Motiva Implants® Post-Approval Study
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Motiva USA LLC
- Study ID
- NCT06938399
- Status
- Recruiting
Conditions
- Breast Implant
Eligibility Criteria
- Sex
- FEMALE
- Age
- 22 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Silicone gel-filled breast implants - Motiva Implants® — DEVICEBreast Surgery
- Aesthetic Surgery — OTHERAesthetic procedure other than breast implant surgery
Study Details
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
Key Dates
- Start date
- May 1, 2025
- Status verified
- Oct 2025
- Primary completion
- Apr 1, 2037
- Completion
- Jul 31, 2037
Study Design
- Enrollment
- 2,400 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: Primary AugmentationSubjects age 22 and over, indicated to increase breast size
- Other: Revision AugmentationRevision surgery to correct or improve the results of a previous breast augmentation
- Other: Control GroupAesthetic procedure other than breast implant surgery
Primary Outcome Measure
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants [ Time Frame: 10 Years ]
Central Contacts
- Motiva USA LLC+506 8761-4436
Locations (30)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| J. Gerald Minniti, M.D., F.A.C.S. | Beverly Hills | California | 90212 | J. Gerald Minniti, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| The Practice Healthcare | Beverly Hills | California | 90210 | Holly Contreras Kelly Killeen, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| AESTHETX Center | Camp Pendleton | California | 95008 | Kamakshi Zeidler, MD, FACS (PRINCIPAL_INVESTIGATOR) Shirley Liu, MD, MHS (SUB_INVESTIGATOR) |
| Los Gatos Plastic Surgery | Los Gatos | California | 95032 | Jerome Liu, MD (PRINCIPAL_INVESTIGATOR) Tom Liu, MD (SUB_INVESTIGATOR) |
| Align Surgical Associates Inc | San Francisco | California | 94115 | Thomas Satterwhite, MD Thomas Satterwhite, MD (PRINCIPAL_INVESTIGATOR) |
| Schwartz Aesthetic Institute | Westlake Village | California | 91361 | Michael Schwartz, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| The Center for Cosmetic Surgery | Denver | Colorado | 80401 | Andrew Wolfe, MD, FACS (PRINCIPAL_INVESTIGATOR) Matthew Freeman, MD (SUB_INVESTIGATOR) |
| Advanced Plastic Surgery, LLC | Washington D.C. | District of Columbia | 20037 | Troy Pittman, MD, FACS (PRINCIPAL_INVESTIGATOR) Michael Somenek, MD, FACS (SUB_INVESTIGATOR) |
| Careaga Plastic Surgery | Coral Gables | Florida | 33134 | Daniel Carega, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Renee Burke Plastic Surgery, Aesthetics, & Med Spa | South Barrington | Illinois | 60010 | Renee Burke, MD (PRINCIPAL_INVESTIGATOR) |
| CaloAesthetics® Plastic Surgery Center | Louisville | Kentucky | 40222 | Michael Bradley Calobrace, MD, FACS (PRINCIPAL_INVESTIGATOR) Alex Pong, MD, FACS (SUB_INVESTIGATOR) |
| The Wall Center for Plastic Surgery | Shreveport | Louisiana | 71105 | Jodi Marvin Simeon Wall, Jr, MD, FACS (PRINCIPAL_INVESTIGATOR) Holly Wall, MD, FACS (SUB_INVESTIGATOR) |
| Belcara Health | Baltimore | Maryland | 21209 | Sarah McMillan, MD (PRINCIPAL_INVESTIGATOR) |
| Center for Plastic Surgery | Chevy Chase | Maryland | 20815 | Samir. S Rao, MD, FACS (PRINCIPAL_INVESTIGATOR) Arjun Kanuri, MD, MBA (SUB_INVESTIGATOR) |
| Parkcrest Plastic Surgery | St Louis | Missouri | 63141 | Patricia McGuire, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Delaware Valley Plastic Surgery | Cherry Hill | New Jersey | 08003 | Evan Sorokin, MD (PRINCIPAL_INVESTIGATOR) |
| Caroline A. Glicksman MD | Sea Girt | New Jersey | 08750 | Caroline Glicksman, MD, FACS Caroline Glicksman, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Mark D. Epstein, MD, FACS Center for Aesthetic Surgery | Hauppauge | New York | 11788 | Mark Epstein, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Neinstein Plastic Surgery | New York | New York | 10019 | Anna Steve, MD, FRCSC (PRINCIPAL_INVESTIGATOR) |
| Capizzi, MD Cosmetic Surgery & Med Spa | Charlotte | North Carolina | 28203 | Peter Capizzi, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| HKB Cosmetic Surgery | Charlotte | North Carolina | 28078 | Gaurav Bharti, MD, FACS (PRINCIPAL_INVESTIGATOR) Bill G. Kortesis, MD, FACS (SUB_INVESTIGATOR) Shawna R. Kleban, MD (SUB_INVESTIGATOR) Brett W. Baker, MD (SUB_INVESTIGATOR) |
| Jones Plastic Surgery | Oklahoma City | Oklahoma | 73120 | Justin Jones, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Landis Platic Surgery | Tulsa | Oklahoma | 74114 | Dana Mulvey Lesley V. Landis, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Austin Plastic Surgeon | Austin | Texas | 78758 | Johnny Franco, MD (PRINCIPAL_INVESTIGATOR) Sean Arredondo, MD (SUB_INVESTIGATOR) |
| Restora Austin Plastic Surgery Center | Austin | Texas | 78705 | Ashley Gordon, MD, FACS (PRINCIPAL_INVESTIGATOR) Dustin Reid, MD, FACS (SUB_INVESTIGATOR) |
| Dallas Day Surgery of Texas North | Dallas | Texas | 75231 | Barbie Reed, RN Sam Jejurikar, MD, MBA (PRINCIPAL_INVESTIGATOR) |
| Southwest Plastic Surgery | El Paso | Texas | 79936 | Francisco Agullo, MD (PRINCIPAL_INVESTIGATOR) |
| Kristy Hamilton MD, FACS | Houston | Texas | 77027 | Kristy Hamilton, MD FACS (PRINCIPAL_INVESTIGATOR) |
| North Texas Plastic Surgery | Southlake | Texas | 76092 | Sacha Obaid, MD (PRINCIPAL_INVESTIGATOR) |
| The Plastics Clinic & SPA | South Jordan | Utah | 84095 | Bryan Pyfer, MD, FACS (SUB_INVESTIGATOR) Brent Robinson, MD, FACS (SUB_INVESTIGATOR) Jeremy Chidester, MD (PRINCIPAL_INVESTIGATOR) Jason Hancey, MD (SUB_INVESTIGATOR) |