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Breast Implants
MemoryShape + MemoryGel Breast Implants for Breast Surgery (Glow Trial)
N/A
Waitlist Available
Research Sponsored by Mentor Worldwide, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and is at least 18 years old;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is collecting data on how well MemoryShape and MemoryGel breast implants work in the long term.
Who is the study for?
This trial is for individuals at least 22 years old seeking primary or revision breast augmentation, or those at least 18 years old looking into breast reconstruction. Participants must be able to sign consent forms, have an email and internet access for online surveys, agree to return implants if removed, and follow the study's check-up schedule.
What is being tested?
The study is evaluating the long-term performance of two types of breast implants: MemoryShape® and MemoryGel®. It aims to gather more data after these products were approved. The research includes people who are getting these implants for the first time or as a replacement.
What are the potential side effects?
While not explicitly listed in this summary, common side effects from breast implant surgery can include pain, swelling, infection risk around the implant area, changes in nipple sensation, scarring and potential implant leakage or rupture.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for breast implants and meet the age requirement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Effectiveness
Other study objectives
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Cognitive Function Abilities
PROMIS (Patient-Reported Outcome Measures Information System) Health Measure Questionnaire for Fatigue
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Revision Breast ReconstructionExperimental Treatment2 Interventions
Participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
Group II: Revision Breast AugmentationExperimental Treatment2 Interventions
Participants who meet the requirements for revision breast augmentation (have had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast implants
Group III: Primary Breast ReconstructionExperimental Treatment2 Interventions
Participants who meet the requirements for primary breast reconstruction (have not had previous silicone or saline breast implants, not including tissue expanders) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
Group IV: Primary Breast AugmentationExperimental Treatment2 Interventions
Participants who meet the requirements for primary breast augmentation (have not had previous silicone or saline breast implants) and have been implanted with Mentor MemoryGel® Breast Implants or MemoryShape® Breast Implants
Group V: Other Aesthetic SurgeryActive Control1 Intervention
Participants who meet the requirements for other aesthetic surgery procedures, which may not include silicone implants (breast or otherwise)
Find a Location
Who is running the clinical trial?
Mentor Worldwide, LLCLead Sponsor
24 Previous Clinical Trials
49,325 Total Patients Enrolled
6 Trials studying Breast Augmentation
46,487 Patients Enrolled for Breast Augmentation
Medical DirectorStudy DirectorMentor Worldwide, LLC
2,881 Previous Clinical Trials
8,084,589 Total Patients Enrolled
1 Trials studying Breast Augmentation
3,811 Patients Enrolled for Breast Augmentation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have signed a form acknowledging I understand the trial.You have an email address and can use the internet to fill out online surveys.You agree to give back the medical device(s) to the manufacturer, Mentor, if it is removed during the study.You agree to answer the baseline questions.I am eligible for breast implants and meet the age requirement.I agree to follow the study's rules and visit my doctor as told.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Breast Augmentation
- Group 2: Revision Breast Augmentation
- Group 3: Primary Breast Reconstruction
- Group 4: Revision Breast Reconstruction
- Group 5: Other Aesthetic Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Breast Augmentation Patient Testimony for trial: Trial Name: NCT02919592 — N/A
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