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Breast Implant
MemoryGel Breast Implants for Breast Reconstruction (Athena 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
A candidate for revision surgery in women at least 18 years old with surgically absent breast tissue
A candidate for primary breast reconstruction in women at least 18 years old with surgically absent breast tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 year
Awards & highlights
Athena Trial Summary
This trial will study the safety and effectiveness of larger Mentor MemoryGel breast implants.
Who is the study for?
This trial is for women at least 18 years old needing primary or revision breast reconstruction due to absent breast tissue. Participants must agree to follow-up visits, return the implant if removed, and have a suitable body mass index (BMI) and chest width. Exclusions include pregnancy, uncontrolled diabetes, recent nursing of a child, conditions affecting wound healing or posing surgical risks, untreated breast cancer, certain autoimmune diseases or immune deficiencies.Check my eligibility
What is being tested?
The safety and effectiveness of Mentor MemoryGel Larger Size Ultra High Profile Breast Implants are being tested in women undergoing primary or revision breast reconstruction. The study focuses on how well these larger implants work and monitors any complications that may arise post-surgery.See study design
What are the potential side effects?
Potential side effects from using these implants can include pain at the surgery site, infection around the implant, changes in nipple sensation, scar tissue formation causing stiffness (capsular contracture), possible rupture of the implant with leakage of silicone gel material.
Athena Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 needing surgery to revise a previous breast operation.
Select...
I am a woman over 18 needing breast reconstruction due to surgery.
Athena Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 year
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 Any Reoperation
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement
+1 moreAthena Trial Design
2Treatment groups
Experimental Treatment
Group I: Revision Breast ReconstructionExperimental Treatment1 Intervention
participants who meet the requirements for revision breast reconstruction (have had previous silicone or saline breast implants) and have been implanted with Mentor Larger Size MemoryGel Ultra High Profile Breast implants
Group II: Primary Breast ReconstructionExperimental Treatment1 Intervention
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 Larger Size MemoryGel Ultra High Profile Breast implants
Find a Location
Who is running the clinical trial?
Mentor Worldwide, LLCLead Sponsor
24 Previous Clinical Trials
52,538 Total Patients Enrolled
10 Trials studying Breast Reconstruction
46,813 Patients Enrolled for Breast Reconstruction
John Canady, M.D.Study DirectorMentor Worldwide, LLC
3 Previous Clinical Trials
45,337 Total Patients Enrolled
3 Trials studying Breast Reconstruction
45,337 Patients Enrolled for Breast Reconstruction
Medical DirectorStudy DirectorMentor Worldwide, LLC
2,777 Previous Clinical Trials
8,063,464 Total Patients Enrolled
2 Trials studying Breast Reconstruction
3,828 Patients Enrolled for Breast Reconstruction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any infections or abscesses.I have a rheumatological autoimmune disease or a weakened immune system.I will need a special material used during my implant surgery.I am HIV positive.I am a woman over 18 needing surgery to revise a previous breast operation.I am over 18 and need surgery to revise a previous breast reconstruction.I have a condition that could affect how my wounds heal.My breast tissue is not suitable for an implant.My doctor agrees the implant size is right for my body type.I am a woman and I am 18 years old or older.I am currently smoking or have smoked within the last 3 months.My diabetes is not under control right now.I have a health condition that makes surgery too risky.I am a woman over 18 needing breast reconstruction due to surgery.I have a condition that could cause serious problems after surgery.My breast cancer has not been treated or was not treated properly, and I haven't had surgery for it.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Breast Reconstruction
- Group 2: Revision Breast Reconstruction
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical experiment require any additional participants?
"Evidence hosted on clinicaltrials.gov reveals that, as of this moment, the study is not open for recruitment. The trial was initially announced on April 1st 2016 and had its last update recorded at November 28th 2022. However, there are two additional trials actively seeking participants currently."
Answered by AI
In which locations is this clinical trial in effect?
"This trial is presently being conducted across 30 sites, comprising of Philadelphia, Scottsdale, Stanford and other nearby locations. Therefore, it would be opportune to pick a location near you in order to decrease travel needs if you become part of the study."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Arizona
Other
California
How old are they?
18 - 65
What site did they apply to?
The Mount Sinai Medical Center
Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB)
Susan E Downey MD, Inc
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Hopefully this trail will help me with my current issue with my breast. I currently have implants that were implanted 10/18/2022 and they were done badly. Hoping for a revision. I had no complications first time.. got through it very well.
PatientReceived 1 prior treatment
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