RECRUITING

Motiva Implants® Post-Approval Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2037-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06938399

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sofia Chaves-Chen, PharmD
CONTACT
+506 8569-2422
schaves@establishmentalbs.com

Study Locations (Sites)

Schwartz Aesthetic Institute
Westlake Village, California, 91361
United States
Advanced Plastic Surgery, LLC
Washington, District of Columbia, 20037
United States
CaloAesthetics® Plastic Surgery Center
Louisville, Kentucky, 40222
United States
The Wall Center for Plastic Surgery
Shreveport, Louisiana, 71105
United States
Parkcrest Plastic Surgery
St. Louis, Missouri, 63141
United States
Mark D. Epstein, MD, FACS Center for Aesthetic Surgery
Hauppauge, New York, 11788
United States
Capizzi, MD Cosmetic Surgery & Med Spa
Charlotte, North Carolina, 28203
United States
Restora Austin Plastic Surgery Center
Austin, Texas, 78705
United States

Collaborators and Investigators

Sponsor: Motiva USA LLC

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 Registration Dates

Study Start Date2025-05-01
Study Completion Date2037-07-31

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2037-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Implant