Actively Recruiting

Phase Not Applicable
Age: 22Years +
FEMALE
Healthy Volunteers
NCT06938399

Motiva Implants® Post-Approval Study

Led by Motiva USA LLC · Updated on 2026-03-27

2400

Participants Needed

29

Research Sites

639 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Motiva Implants® Post-Approval Study

Who Can Participate

Age: 22Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Seeking primary breast augmentation at age 22 or older to increase breast size
  • Seeking revision breast augmentation to remove and replace breast implants
  • Has adequate tissue to cover implants
  • Willing to follow all study requirements
  • Signs an informed consent
  • Agrees to return device to sponsor if explanted
  • Willing to undergo CT, ultrasound, or MRI if medically advised
  • Control group: female, 22 years or older, candidate for aesthetic surgery other than breast implants
  • Control group: signs informed consent and willing to follow study requirements
Not Eligible

You will not qualify if you...

  • Has pre-malignant breast disease or BRCA1/BRCA2 mutations
  • Has inadequate or unsuitable tissue due to radiation, ulceration, poor vascularity, or wound healing issues
  • Has an active infection anywhere in the body
  • Is pregnant, nursing, or recently pregnant/lactated within 6 months
  • Takes drugs interfering with blood clotting or increasing surgical risk
  • Has obesity (BMI >40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease
  • Has connective tissue/autoimmune or rheumatoid disorders like lupus, scleroderma, or rheumatoid arthritis
  • Has unrealistic psychological characteristics for surgery risks
  • Has any non-FDA approved breast implant or non-breast silicone implant
  • Is HIV positive
  • Diagnosed with Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
  • Control group exclusions: history of silicone implants, plans for silicone breast implant surgery, active infection, history of cancer (except skin cancer), blood clotting interfering drugs, high-risk medical conditions, connective tissue or autoimmune disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

The Practice Healthcare

Beverly Hills, California, United States, 90210

Actively Recruiting

2

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

Beverly Hills, California, United States, 90212

Actively Recruiting

3

AESTHETX Center

Camp Pendleton, California, United States, 95008

Actively Recruiting

4

Align Surgical Associates Inc

San Francisco, California, United States, 94115

Actively Recruiting

5

Schwartz Aesthetic Institute

Westlake Village, California, United States, 91361

Actively Recruiting

6

The Center for Cosmetic Surgery

Denver, Colorado, United States, 80401

Actively Recruiting

7

Advanced Plastic Surgery, LLC

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

Actively Recruiting

8

Careaga Plastic Surgery

Coral Gables, Florida, United States, 33134

Actively Recruiting

9

Renee Burke Plastic Surgery, Aesthetics, & Med Spa

South Barrington, Illinois, United States, 60010

Actively Recruiting

10

CaloAesthetics® Plastic Surgery Center

Louisville, Kentucky, United States, 40222

Actively Recruiting

11

The Wall Center for Plastic Surgery

Shreveport, Louisiana, United States, 71105

Actively Recruiting

12

Belcara Health

Baltimore, Maryland, United States, 21209

Actively Recruiting

13

Center for Plastic Surgery

Chevy Chase, Maryland, United States, 20815

Actively Recruiting

14

Parkcrest Plastic Surgery

St Louis, Missouri, United States, 63141

Actively Recruiting

15

Delaware Valley Plastic Surgery

Cherry Hill, New Jersey, United States, 08003

Actively Recruiting

16

Caroline A. Glicksman MD

Sea Girt, New Jersey, United States, 08750

Actively Recruiting

17

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

Hauppauge, New York, United States, 11788

Actively Recruiting

18

Neinstein Plastic Surgery

New York, New York, United States, 10019

Actively Recruiting

19

HKB Cosmetic Surgery

Charlotte, North Carolina, United States, 28078

Actively Recruiting

20

Capizzi, MD Cosmetic Surgery & Med Spa

Charlotte, North Carolina, United States, 28203

Actively Recruiting

21

Jones Plastic Surgery

Oklahoma City, Oklahoma, United States, 73120

Actively Recruiting

22

Landis Platic Surgery

Tulsa, Oklahoma, United States, 74114

Actively Recruiting

23

Restora Austin Plastic Surgery Center

Austin, Texas, United States, 78705

Actively Recruiting

24

Austin Plastic Surgeon

Austin, Texas, United States, 78758

Actively Recruiting

25

Dallas Day Surgery of Texas North

Dallas, Texas, United States, 75231

Actively Recruiting

26

Southwest Plastic Surgery

El Paso, Texas, United States, 79936

Actively Recruiting

27

Kristy Hamilton MD, FACS

Houston, Texas, United States, 77027

Actively Recruiting

28

North Texas Plastic Surgery

Southlake, Texas, United States, 76092

Actively Recruiting

29

The Plastics Clinic & SPA

South Jordan, Utah, United States, 84095

Actively Recruiting

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Research Team

M

Motiva USA LLC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Motiva Implants® Post-Approval Study | DecenTrialz