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Athena: A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction

Sponsor
Mentor Worldwide, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02724371
Collaborator
(none)
400
Enrollment
30
Locations
2
Arms
154
Anticipated Duration (Months)
13.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.

Condition or Disease Intervention/Treatment Phase
  • Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
 N/A

Detailed Description

Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of the Safety and Effectiveness of the Mentor Smooth and Textured Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Actual Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Jan 31, 2029
Anticipated Study Completion Date :
Jan 31, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Primary Breast Reconstruction

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

Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
Other Names:
  • UHP-L Breast Implant

    		•
    Experimental: Revision Breast Reconstruction

    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

    Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
    The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
    Other Names:
  • UHP-L Breast Implant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation [10 years]

    2. 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture [10 year]

    3. 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection [10 year]

    4. 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subject is female and is at least 18 years old

    • A candidate for:

    • Primary breast reconstruction in women at least 18 years old with surgically absent breast tissue (two-stage reconstruction [tissue expanders utilized with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement] to replace breast tissue post-mastectomy)

    • Revision surgery in women at least 18 years old with surgically absent breast tissue (previous reconstruction with silicone-filled or saline-filled implants or revision reconstruction requiring expansion surgery prior to surgery for study device implantation, with or without the use of human acellular dermal matrices (ADM), limited to AlloDerm® and FlexHD® PLIABLE, utilized in a prior surgery to expand tissue for study device placement)

    • Subject understands and signs the Informed Consent

    • Subject agrees to return device to Mentor if device is explanted

    • Subject agrees to comply with follow-up procedures, including returning for all follow-up visits

    • Physician determines implant volume appropriate for the patient taking into account the subject's BMI and chest width

    Exclusion Criteria:

    • Subject is pregnant at time of enrollment

    • Subject is a current smoker, or has smoked within 3 months prior to enrollment, or plans to resume smoking within 3 months post-enrollment

    • Currently has uncontrolled diabetes (at time of screening or enrollment)

    • Has nursed a child within 3 months of study enrollment

    • Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome

    • Currently has a condition that could compromise or complicate wound healing. Note, obesity alone is not an exclusion. All surgical risk factors (obesity, diabetes, smoking history, and prior radiation) should be considered in totality for proper subject selection

    • Infection or abscess anywhere in the body

    • Demonstrates tissue characteristics that are clinically incompatible with successful use of a breast implant (e.g. inadequate tissue or compromised vascularity)

    • Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk

    • Anatomic or physiologic abnormality that could lead to significant postoperative adverse events

    • Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure

    • Untreated active, or inappropriately/inadequately treated breast malignancy, without surgical treatment

    • Anticipated need for use of ADM/mesh at the time of implant or implant exchange

    • Subject is HIV positive

    • Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor

    • Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Plastic Surgery Associates of Montgomery Montgomery Alabama United States 36117
    2 Mosharrafa Plastic Surgery Phoenix Arizona United States 85028
    3 Mayo Clinic Arizona - Scottsdale/Phoenix (MCSB) Phoenix Arizona United States 85054
    4 Andres Plastic Surgery Scottsdale Arizona United States 85260
    5 Adventist Health Bakersfield Bakersfield California United States 93301
    6 Susan E Downey MD, Inc Burbank California United States 91505
    7 Liu Plastic Surgery Los Gatos California United States 95032
    8 Stanford University School of Medicine Stanford California United States 94305
    9 Buckhead Plastic Surgery, P.C Atlanta Georgia United States 30342
    10 Georgia Institute of Plastic Surgery Savannah Georgia United States 31405
    11 The Centre, PC Mishawaka Indiana United States 46545
    12 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    13 The University of Kansas Kansas City Kansas United States 66160
    14 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
    15 Washington University School of Medicine Saint Louis Missouri United States 63110
    16 The Mount Sinai Medical Center New York New York United States 10029
    17 Plastic Surgery Institute of Dayton Centerville Ohio United States 45458
    18 The Plastic Surgery Group Cincinnati Ohio United States 45227
    19 The Cleveland Clinic Cleveland Ohio United States 44195
    20 The Ohio State University Plastic Surgery Columbus Ohio United States 43212
    21 Legacy Good Samaritan Medical Center Portland Oregon United States 97210
    22 Paul Glat, MD, PC Bala-Cynwyd Pennsylvania United States 19087
    23 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    24 The Center for Dermatology and Plastic Surgery at Springbrook Alcoa Tennessee United States 37701
    25 The Plastic Surgery Group PC Chattanooga Tennessee United States 37403
    26 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    27 Houston Methodist Hospital Houston Texas United States 77030
    28 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    29 Baylor Scott & White Health Temple Texas United States 76508
    30 UVA Health System Charlottesville Virginia United States 22903

    Sponsors and Collaborators

    • Mentor Worldwide, LLC

    Investigators

    • Study Director: Medical Director, Mentor Worldwide, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mentor Worldwide, LLC
    ClinicalTrials.gov Identifier:
    NCT02724371
    Other Study ID Numbers:
    • MEN-15-001
    First Posted:
    Mar 31, 2016
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Aug 9, 2022