Health TrialsbyHealthPanel

Motiva Implants® Post-Approval Study

ConditionBreast Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorMotiva USA LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silicone gel-filled breast implants - Motiva Implants®

    Device

    Breast Surgery

  • Aesthetic Surgery

    Other intervention

    Aesthetic procedure other than breast implant surgery

Treatment groups

2,400 Participants
are divided into 3 treatment groups
Group A: Primary AugmentationOther 1 intervention
Group B: Revision AugmentationOther 1 intervention
Group C: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants

Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey

Time frame
10 Years

Secondary outcomes

1

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

Analysis of Patient-Reported safety and satisfaction collected through a Follow-Up Questionnaire and 5-point Likert scale

Time frame
10 Years
2

Assess the impact of RFID on imaging

Frequency of imaging impact among participants implanted with devices containing RFID

Time frame
10 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Motiva USA LLC

Lead sponsor

Source ClinicalTrials.gov
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