Recruiting

Motiva Implants®

Sponsor:

Motiva USA LLC

Code:

NCT06938399

Conditions

Breast Implant

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Accepted

Interventions

Silicone gel-filled breast implants - Motiva Implants®

Aesthetic Surgery

Study Details

Brief summary:

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.

Conditions

Breast Implant

Study ID

NCT06938399

Start date

May 1, 2025

Status verified date

Oct, 2025

Completion date

Jul 31, 2037

Anticipated

Primary completion date

Apr 1, 2037

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria Motiva Implants®:

  • Female
  • Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation
  • Patient has adequate tissue available to cover implant(s)
  • Willingness to follow all study requirements
  • Signs an Informed Consent
  • Agrees to have device returned to the Sponsor, if explanted
  • Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised

Inclusion Criteria Control group:

  • Is 22 years of age or older
  • Female
  • Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)
  • Signs an Informed Consent
  • Willingness to follow all study requirements

Exclusion Criteria Motiva Implants®:

  • Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2
  • Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)
  • Has an active infection anywhere in their body
  • Is pregnant or nursing, or has had a full-term pregnancy or lactated within 6 months of enrollment
  • Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and/or significant postoperative complications
  • Has any medical condition such as obesity (BMI >40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and/or significant postoperative complications
  • Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others
  • Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
  • Has been implanted with any non-FDA approved breast implant
  • Has been implanted with any silicone implant other than breast implants
  • HIV positive (based on medical history)
  • Has been diagnosed with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)

Exclusion Criteria Control group:

  • Has a history of silicone implants (anywhere in the body)
  • Plans to undergo silicone breast implant surgery during the course of the study
  • Has an active infection anywhere in their body
  • Has a history of cancer (except skin cancer)
  • Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and/or significant postoperative complications
  • Has any medical condition such as obesity (BMI >40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and/or significant postoperative complications
  • Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Primary Augmentation

Subjects age 22 and over, indicated to increase breast size

other: Revision Augmentation

Revision surgery to correct or improve the results of a previous breast augmentation

other: Control Group

Aesthetic procedure other than breast implant surgery

Interventions

Silicone gel-filled breast implants - Motiva Implants®

Breast Surgery

Aesthetic Surgery

Aesthetic 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 and Locations

Central contacts

Motiva USA LLC

+506 86263002CIP-001005+enrollment@establishmentlabs.com

Locations

The Practice Healthcare

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Holly Contreras

hollyc@thepracticehealthcare.com

Principal Investigator:

Kelly Killeen, MD, FACS

J. Gerald Minniti, M.D., F.A.C.S.

Recruiting

Beverly Hills, California, United States, 90212

Contacts

Samantha Miles

310-275-004samantha@drminniti.com

Principal Investigator:

J. Gerald Minniti, MD, FACS

AESTHETX Center

Recruiting

Camp Pendleton, California, United States, 95008

Contacts

Kamakshi Zeidler, MD, FACS

408-559-7177drz@aesthetx.com

Principal Investigator:

Kamakshi Zeidler, MD, FACS

Los Gatos Plastic Surgery

Recruiting

Los Gatos, California, United States, 95032

Contacts

Emily McMaster

408-559-7177emily@sviaplasticsurgery.com

Principal Investigator:

Jerome Liu, MD

Align Surgical Associates Inc

Recruiting

San Francisco, California, United States, 94115

Contacts

Thomas Satterwhite, MD

Office@AlignSurgical.com

Principal Investigator:

Thomas Satterwhite, MD

Schwartz Aesthetic Institute

Recruiting

Westlake Village, California, United States, 91361

Contacts

Stephanie Cohen, RN

805-706-0742rn@drschwartz.com

Principal Investigator:

Michael Schwartz, MD, FACS

The Center for Cosmetic Surgery

Recruiting

Denver, Colorado, United States, 80401

Contacts

Jen Atkinson

303-907-0077leads@denverccs.com

Principal Investigator:

Andrew Wolfe, MD, FACS

Advanced Plastic Surgery, LLC

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Troy Pittman, MD, FACS

202-915-2362drpittman@spmeddc.com

Principal Investigator:

Troy Pittman, MD, FACS

Careaga Plastic Surgery

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Barbara Garcia

305-960-7511bgarcia@absolutemedicalcenter.com

Principal Investigator:

Daniel Carega, MD, FACS

Alicia Billington Plastic Surgery LLC

Recruiting

St. Petersburg, Florida, United States, 33712

Contacts

Alicia Billington MD

727 341 0337Alicia@billingtonmd.com

Iteld Plastic Surgery

Recruiting

Chicago, Illinois, United States, 60642

Contacts

Lawrence Iteld MD

312-757-4505Info@driteld.com

Renee Burke Plastic Surgery, Aesthetics, & Med Spa

Recruiting

South Barrington, Illinois, United States, 60010

Contacts

Luiza Ramanoska

847-382-4400luiza@reneeburkemd.com

Principal Investigator:

Renee Burke, MD

CaloAesthetics® Plastic Surgery Center

Recruiting

Louisville, Kentucky, United States, 40222

Contacts

Michael Bradley Calobrace, MD, FACS

502-814-3016SurgeryCoordinators@calobrace.com

Principal Investigator:

Michael Bradley Calobrace, MD, FACS

The Wall Center for Plastic Surgery

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

Terry Brantley

318-795-0801info@wallcenter.com

Jodi Marvin

info@wallcenter.com

Principal Investigator:

Simeon Wall, Jr, MD, FACS

Belcara Health

Recruiting

Baltimore, Maryland, United States, 21209

Contacts

Sarah McMillan, MD

(410) 296-0414drmcmillan@belcarahealth.com

Principal Investigator:

Sarah McMillan, MD

Center for Plastic Surgery

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Diana Altman, RN

301-888-7264Diana@cpsdocs.com

Principal Investigator:

Samir. S Rao, MD, FACS

Parkcrest Plastic Surgery

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Patricia McGuire, MD, FACS

314-569-0130jodig@parkcrestplasticsurgery.com

Principal Investigator:

Patricia McGuire, MD, FACS

Delaware Valley Plastic Surgery

Recruiting

Cherry Hill, New Jersey, United States, 08003

Contacts

Evan Sorokin, MD

856-797-0202esorokin@delawarevalleyplasticsurgery.com

Principal Investigator:

Evan Sorokin, MD

Caroline A. Glicksman MD

Recruiting

Sea Girt, New Jersey, United States, 08750

Contacts

Caroline Glicksman, MD, FACS

drglicksman.office@gmail.com

Principal Investigator:

Caroline Glicksman, MD, FACS

Mark D. Epstein, MD, FACS Center for Aesthetic Surgery

Recruiting

Hauppauge, New York, United States, 11788

Contacts

Kimberly Wagner

631-689-1100kwagner@epsteinplasticsurgery.com

Principal Investigator:

Mark Epstein, MD, FACS

Neinstein Plastic Surgery

Recruiting

New York, New York, United States, 10019

Contacts

Anne Steve, MD

212-249-0949mimi@neinsteinplasticsurgery.com

Principal Investigator:

Anna Steve, MD, FRCSC

HKB Cosmetic Surgery

Recruiting

Charlotte, North Carolina, United States, 28078

Contacts

Devin B. White

704-659-9000devin@hkbsurgery.com

Principal Investigator:

Gaurav Bharti, MD, FACS

Capizzi, MD Cosmetic Surgery & Med Spa

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Peter Capizzi, MD, FACS

704-655-8988patientcare@capizzimd.com

Principal Investigator:

Peter Capizzi, MD, FACS

Jones Plastic Surgery

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Lori Podany, RN

(405) 848-3459nurse@drjustinjones.com

Principal Investigator:

Justin Jones, MD, FACS

Landis Platic Surgery

Recruiting

Tulsa, Oklahoma, United States, 74114

Contacts

Dana Mulvey

dana@landisplasticsurgery.com

Principal Investigator:

Lesley V. Landis, MD, FACS

Restora Austin Plastic Surgery Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Ashley Gordon, MD, FACS

512-371-8817ashleygordonmd@gmail.com

Principal Investigator:

Ashley Gordon, MD, FACS

Austin Plastic Surgeon

Recruiting

Austin, Texas, United States, 78758

Contacts

Johnny Franco, MD

512-334-9917Jchervanik@morebeautifulyou.com

Principal Investigator:

Johnny Franco, MD

Dallas Day Surgery of Texas North

Recruiting

Dallas, Texas, United States, 75231

Contacts

Barbie Reed, RN

barbie.reed@dpsi.org

Principal Investigator:

Sam Jejurikar, MD, MBA

Southwest Plastic Surgery

Recruiting

El Paso, Texas, United States, 79936

Contacts

Marcela Aguilar

915-590-7900marcy@swplasticsurgery.com

Principal Investigator:

Francisco Agullo, MD

Aesthetic Center for Plastic Surgery

Recruiting

Houston, Texas, United States, 77024

Contacts

Kirk Zihlman Clinical Research Director

832-647-3417kzihlman@kalonaesthetics.com

Principal Investigator:

Kristi Hustak, MD

Kristy Hamilton MD, FACS

Recruiting

Houston, Texas, United States, 77027

Contacts

Liliana Hernandez

713-770-6257info@drkristyhamilton.com

Principal Investigator:

Kristy Hamilton, MD FACS

North Texas Plastic Surgery

Recruiting

Southlake, Texas, United States, 76092

Contacts

Sandy Roos, MD

817-587-0884sandy@northtexasps.com

Principal Investigator:

Sacha Obaid, MD

The Plastics Clinic & SPA

Recruiting

South Jordan, Utah, United States, 84095

Contacts

KinCaid Fajardo

801-839-5557kincaid@theplasticsclinic.com

Principal Investigator:

Jeremy Chidester, MD

More Information

Sponsor

Motiva USA LLC

Last update posted

Jul 17, 2026

Last verified

Oct, 2025

Keywords

  • Breast Implants
  • Breast Surgery
  • Breast Augmentation
  • Breast Revision
  • Silicone Implants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Motiva USA LLC on 2026-07-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.