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Silicone gel-filled breast implants

Motiva Implants® for Breast Enhancement

N/A
Waitlist Available
Research Sponsored by Motiva USA LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Genetic female
Patient is seeking one of the following procedures: Primary Breast Augmentation, Primary Breast Reconstruction, Revision Augmentation, Revision Reconstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial looks at the safety and effectiveness of a new breast implant.

Who is the study for?
This trial is for genetic females seeking breast augmentation, reconstruction, or revision surgery. Candidates must have enough tissue to cover the implants and be willing to follow study protocols, including MRI scans if needed. Exclusions include those with certain medical conditions, high surgical risks like obesity or diabetes, previous non-FDA approved implants, or a history of specific breast diseases.Check my eligibility
What is being tested?
The safety and effectiveness of Motiva Implants® are being tested in women undergoing primary breast augmentation or reconstruction, as well as those having revision surgeries. The study monitors how these silicone gel-filled implants perform over time.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from similar procedures may include pain at the implant site, infection potential around the implant area, changes in nipple sensation, rupture risk of the implant material leading to additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am genetically female.
Select...
I am considering a breast surgery, either for the first time or as a revision.
Select...
I have enough tissue to cover the breast implant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.
Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.
Secondary outcome measures
Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline
Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture
Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Revision ReconstructionExperimental Treatment1 Intervention
Revision surgery to correct or improve the results of a previous breast reconstruction.
Group II: Revision AugmentationExperimental Treatment1 Intervention
Revision surgery to correct or improve the results of a previous breast augmentation
Group III: Primary Breast ReconstructionExperimental Treatment1 Intervention
Subjects age 18 and over, Surgery to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly.
Group IV: Primary Breast AugmentationExperimental Treatment1 Intervention
Subjects age 22 and over, indicated to increase breast size

Find a Location

Who is running the clinical trial?

Motiva USA LLCLead Sponsor
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Motiva Implants® (Silicone gel-filled breast implants) Clinical Trial Eligibility Overview. Trial Name: NCT03579901 — N/A
Breast Implants Research Study Groups: Revision Reconstruction, Primary Breast Reconstruction, Revision Augmentation, Primary Breast Augmentation
Breast Implants Clinical Trial 2023: Motiva Implants® Highlights & Side Effects. Trial Name: NCT03579901 — N/A
Motiva Implants® (Silicone gel-filled breast implants) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03579901 — N/A
Breast Implants Patient Testimony for trial: Trial Name: NCT03579901 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals beneath the age of 25 able to participate in this experiment?

"In agreement with the regulations of this clinical trial, participants must be aged 18 and above whilst not exceeding 70 years old."

Answered by AI

In which venues is this clinical research being conducted?

"There are 19 medical centres offering this research, with Northwestern Specialists in Plastic Surgery in Chicago, Cleaveland Clinic in Cleveland and Peacehealth Medical Group Plastic Surgery in Vancouver among them."

Answered by AI

Are there any vacancies in this clinical trial that could be filled by participants?

"According to the information posted on clinicaltrials.gov, this study is no longer actively seeking participants. It was initially published in April 2018 and last updated late August 2022. Nonetheless, there are two other trials that are currently recruiting patients for enrolment."

Answered by AI

What criteria must individuals fulfill to qualify for this research experiment?

"This clinical trial is enrolling 800 individuals, aged 18 to 70 years old. These participants must have a breast implant and enough tissue coverage for the device as well as meet genetic female criteria."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
California
Texas
Other
How old are they?
18 - 65
What site did they apply to?
MD Anderson Cancer Center
Westlake Cosmetic Surgery Center
Brian M. Kinney, M.D., F.A.C.S.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

What questions have other patients asked about this trial?

How long is screening? How long til I get a response? When should I expect to hear back ? And when does the trial start date?
PatientReceived no prior treatments
Would I be responsible for any cost? Would compensation for travel be offered?
PatientReceived 1 prior treatment
What does recovery look like? Any out of pocket expenses? How many days will I need off work? How soon could I get started?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Hand 3 kids. Being a clinical tester. I want the best implant. Self motivation from domestic violence.
PatientReceived 1 prior treatment
I’m planning on getting breast implants.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Rafael Gottenger, MD Plastic Surgery: < 24 hours
  2. Westlake Cosmetic Surgery Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Effectiveness of Motiva Implants®
2018. "Study of the Safety and Effectiveness of Motiva Implants®". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03579901.
All > Rhode Island
~465 spots leftby Aug 2032
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