🏛️ Verified NIH Record • Updated 2026-07-15

Motiva Implants® Post-Approval Study (NCT06938399)

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

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Motiva USA LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: The Practice Healthcare — Beverly Hills, California

Age range: 22 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (33 Sites)

Showing the first 25 of 33 sites.

  • The Practice Healthcare — Beverly Hills, California
  • J. Gerald Minniti, M.D., F.A.C.S. — Beverly Hills, California
  • AESTHETX Center — Camp Pendleton, California
  • Los Gatos Plastic Surgery — Los Gatos, California
  • Align Surgical Associates Inc — San Francisco, California
  • Schwartz Aesthetic Institute — Westlake Village, California
  • The Center for Cosmetic Surgery — Denver, Colorado
  • Advanced Plastic Surgery, LLC — Washington D.C., District of Columbia
  • Careaga Plastic Surgery — Coral Gables, Florida
  • Alicia Billington Plastic Surgery LLC — St. Petersburg, Florida
  • Iteld Plastic Surgery — Chicago, Illinois
  • Renee Burke Plastic Surgery, Aesthetics, & Med Spa — South Barrington, Illinois
  • CaloAesthetics® Plastic Surgery Center — Louisville, Kentucky
  • The Wall Center for Plastic Surgery — Shreveport, Louisiana
  • Belcara Health — Baltimore, Maryland
  • Center for Plastic Surgery — Chevy Chase, Maryland
  • Parkcrest Plastic Surgery — St Louis, Missouri
  • Delaware Valley Plastic Surgery — Cherry Hill, New Jersey
  • Caroline A. Glicksman MD — Sea Girt, New Jersey
  • Mark D. Epstein, MD, FACS Center for Aesthetic Surgery — Hauppauge, New York
  • Neinstein Plastic Surgery — New York, New York
  • HKB Cosmetic Surgery — Charlotte, North Carolina
  • Capizzi, MD Cosmetic Surgery & Med Spa — Charlotte, North Carolina
  • Jones Plastic Surgery — Oklahoma City, Oklahoma
  • Landis Platic Surgery — Tulsa, Oklahoma

📞 Contact the Study Coordinator

Phone: +506 86263002

Email: CIP-001005+enrollment@establishmentlabs.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Implant clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗