Motiva Implants® Post-Approval Study (Motiva PAS)

July 15, 2026 updated by: Motiva USA LLC

Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • J. Gerald Minniti, M.D., F.A.C.S.
        • Principal Investigator:
          • J. Gerald Minniti, MD, FACS
        • Contact:
      • Beverly Hills, California, United States, 90210
      • Camp Pendleton, California, United States, 95008
        • Recruiting
        • AESTHETX Center
        • Contact:
        • Principal Investigator:
          • Kamakshi Zeidler, MD, FACS
        • Sub-Investigator:
          • Shirley Liu, MD, MHS
      • Los Gatos, California, United States, 95032
        • Recruiting
        • Los Gatos Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Jerome Liu, MD
        • Sub-Investigator:
          • Tom Liu, MD
      • San Francisco, California, United States, 94115
        • Recruiting
        • Align Surgical Associates Inc
        • Contact:
        • Principal Investigator:
          • Thomas Satterwhite, MD
      • Westlake Village, California, United States, 91361
        • Recruiting
        • Schwartz Aesthetic Institute
        • Principal Investigator:
          • Michael Schwartz, MD, FACS
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80401
        • Recruiting
        • The Center for Cosmetic Surgery
        • Principal Investigator:
          • Andrew Wolfe, MD, FACS
        • Contact:
        • Sub-Investigator:
          • Matthew Freeman, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • Advanced Plastic Surgery, LLC
        • Contact:
        • Principal Investigator:
          • Troy Pittman, MD, FACS
        • Sub-Investigator:
          • Michael Somenek, MD, FACS
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Careaga Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Daniel Carega, MD, FACS
      • St. Petersburg, Florida, United States, 33712
        • Recruiting
        • Alicia Billington Plastic Surgery LLC
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60642
        • Recruiting
        • Iteld Plastic Surgery
        • Contact:
      • South Barrington, Illinois, United States, 60010
        • Recruiting
        • Renee Burke Plastic Surgery, Aesthetics, & Med Spa
        • Contact:
        • Principal Investigator:
          • Renee Burke, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • Recruiting
        • CaloAesthetics® Plastic Surgery Center
        • Principal Investigator:
          • Michael Bradley Calobrace, MD, FACS
        • Contact:
        • Sub-Investigator:
          • Alex Pong, MD, FACS
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • The Wall Center for Plastic Surgery
        • Principal Investigator:
          • Simeon Wall, Jr, MD, FACS
        • Sub-Investigator:
          • Holly Wall, MD, FACS
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Recruiting
        • Belcara Health
        • Contact:
        • Principal Investigator:
          • Sarah McMillan, MD
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • Center for Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Samir. S Rao, MD, FACS
        • Sub-Investigator:
          • Arjun Kanuri, MD, MBA
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Parkcrest Plastic Surgery
        • Principal Investigator:
          • Patricia McGuire, MD, FACS
        • Contact:
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
      • Sea Girt, New Jersey, United States, 08750
        • Recruiting
        • Caroline A. Glicksman MD
        • Contact:
        • Principal Investigator:
          • Caroline Glicksman, MD, FACS
    • New York
      • Hauppauge, New York, United States, 11788
        • Recruiting
        • Mark D. Epstein, MD, FACS Center for Aesthetic Surgery
        • Principal Investigator:
          • Mark Epstein, MD, FACS
        • Contact:
      • New York, New York, United States, 10019
        • Recruiting
        • Neinstein Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Anna Steve, MD, FRCSC
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Capizzi, MD Cosmetic Surgery & Med Spa
        • Principal Investigator:
          • Peter Capizzi, MD, FACS
        • Contact:
      • Charlotte, North Carolina, United States, 28078
        • Recruiting
        • HKB Cosmetic Surgery
        • Contact:
        • Principal Investigator:
          • Gaurav Bharti, MD, FACS
        • Sub-Investigator:
          • Bill G. Kortesis, MD, FACS
        • Sub-Investigator:
          • Shawna R. Kleban, MD
        • Sub-Investigator:
          • Brett W. Baker, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Jones Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Justin Jones, MD, FACS
      • Tulsa, Oklahoma, United States, 74114
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Restora Austin Plastic Surgery Center
        • Contact:
        • Principal Investigator:
          • Ashley Gordon, MD, FACS
        • Sub-Investigator:
          • Dustin Reid, MD, FACS
      • Austin, Texas, United States, 78758
        • Recruiting
        • Austin Plastic Surgeon
        • Principal Investigator:
          • Johnny Franco, MD
        • Contact:
        • Sub-Investigator:
          • Sean Arredondo, MD
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Dallas Day Surgery of Texas North
        • Contact:
        • Principal Investigator:
          • Sam Jejurikar, MD, MBA
      • El Paso, Texas, United States, 79936
        • Recruiting
        • Southwest Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Francisco Agullo, MD
      • Houston, Texas, United States, 77024
        • Recruiting
        • Aesthetic Center for Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Kristi Hustak, MD
        • Sub-Investigator:
          • Rolando Morales, MD
        • Sub-Investigator:
          • Abigail Rodriguez, MD
        • Sub-Investigator:
          • Kimberly Carpin, MD
        • Sub-Investigator:
          • Monica Wentworth, MD
        • Sub-Investigator:
          • Christopher Patronella, MD
        • Sub-Investigator:
          • David Magno, MD
      • Houston, Texas, United States, 77027
        • Recruiting
        • Kristy Hamilton MD, FACS
        • Principal Investigator:
          • Kristy Hamilton, MD FACS
        • Contact:
      • Southlake, Texas, United States, 76092
        • Recruiting
        • North Texas Plastic Surgery
        • Principal Investigator:
          • Sacha Obaid, MD
        • Contact:
    • Utah
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • The Plastics Clinic & SPA
        • Contact:
        • Sub-Investigator:
          • Bryan Pyfer, MD, FACS
        • Sub-Investigator:
          • Brent Robinson, MD, FACS
        • Principal Investigator:
          • Jeremy Chidester, MD
        • Sub-Investigator:
          • Jason Hancey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Revision Augmentation
Revision surgery to correct or improve the results of a previous breast augmentation
Device: Silicone gel-filled breast implants - Motiva Implants®
Breast Surgery
Other Names:
  • Breast Augmentation
Other: Primary Augmentation
Subjects age 22 and over, indicated to increase breast size
Device: Silicone gel-filled breast implants - Motiva Implants®
Breast Surgery
Other Names:
  • Breast Augmentation
Other: Control Group
Aesthetic procedure other than breast implant surgery
Other: Aesthetic Surgery
Aesthetic procedure other than breast implant surgery
Other Names:
  • Aesthetic procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey
10 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the incidence of Reproductive Complications, Cancer Diagnoses, Local Complications in Motiva implanted participants compared to the incidence in control participants, where data collection allows; and investigate patient satisfaction
Time Frame: 10 Years
Analysis of Patient-Reported safety and satisfaction collected through a Follow-Up Questionnaire and 5-point Likert scale
10 Years
Assess the impact of RFID on imaging
Time Frame: 10 Years
Frequency of imaging impact among participants implanted with devices containing RFID
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Motiva USA LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

April 1, 2037

Study Completion (Estimated)

July 31, 2037

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIP-001005
  • P230005 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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