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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
Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Glow Trial 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.Check my eligibility
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.See study design
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.

Glow Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have signed a form acknowledging I understand the trial.
Select...
I am eligible for breast implants and meet the age requirement.
Select...
I agree to follow the study's rules and visit my doctor as told.

Glow Trial 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
10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications
Secondary outcome measures
Effectiveness
Magnetic Resonance Imaging
Rates of lactation complications
+5 more
Other outcome measures
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

Glow 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
2,769 Previous Clinical Trials
8,058,587 Total Patients Enrolled
1 Trials studying Breast Augmentation
3,811 Patients Enrolled for Breast Augmentation

Media Library

MemoryGel® Breast Implants (Breast Implants) Clinical Trial Eligibility Overview. Trial Name: NCT02919592 — N/A
Breast Augmentation Research Study Groups: Primary Breast Augmentation, Revision Breast Augmentation, Primary Breast Reconstruction, Revision Breast Reconstruction, Other Aesthetic Surgery
Breast Augmentation Clinical Trial 2023: MemoryGel® Breast Implants Highlights & Side Effects. Trial Name: NCT02919592 — N/A
MemoryGel® Breast Implants (Breast Implants) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02919592 — N/A
Breast Augmentation Patient Testimony for trial: Trial Name: NCT02919592 — N/A

Frequently Asked Questions

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

What is the current number of facilities conducting this research trial?

"Patients interested in this clinical trial have the opportunity to participate at Upstate Plastic Surgery in Greer, South carolina, North Atlanta Plastic Surgery in Atlanta, Tennessee and Music City Plastics surgery in Nashville Virginia as well as 78 other medical facilities."

Answered by AI

Is it still possible to sign up for this trial?

"According to the data housed by clinicaltrials.gov, this medical experiment is not actively recruiting patients at present. Initially posted on September 1st 2016 and last amended on November 28th 2022, it has been concluded that no new participants are needed for this trial; however, two other trials remain open to those seeking enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
California
Other
How old are they?
18 - 65
What site did they apply to?
Advanced Surgical Associates
Jaime Schwartz, MD
Music City Plastic Surgery
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How long is the down time ? What is the cost for any procedure? What about recovery time?
PatientReceived no prior treatments
Have there been any other trials with this particular implant and what were the cons/pros? Also, what is the common shape the implants takes after healing?
PatientReceived no prior treatments
Is this only for patients who are in need of reconstructive surgery due to cancer, masectomy, etc? How many days would I need to take off work? What are the dates of the study? What does the recovery from surgery look like? Are there any out of pocket costs? Would I be able to choose my implant size and shape?
PatientReceived no prior treatments

Why did patients apply to this trial?

To boost confidence. I want to feel like a woman please help. I want breast implants for my confidence.
PatientReceived 2+ prior treatments
I've always wanted breat implants so after d. I applied for breast implants to have bigger breast.
PatientReceived no prior treatments
~1755 spots leftby Jun 2031