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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 (Athena)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724371
Recruitment Status : Active, not recruiting
First Posted : March 31, 2016
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC

Tracking Information
First Submitted Date  ICMJE March 21, 2016
First Posted Date  ICMJE March 31, 2016
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE April 1, 2016
Estimated Primary Completion Date January 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2016)
  • 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation [ Time Frame: 10 years ]
  • 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture [ Time Frame: 10 year ]
  • 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection [ Time Frame: 10 year ]
  • 10 Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation with or without replacement [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Reconstruction, Revision Breast Reconstruction
Intervention  ICMJE 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 Name: UHP-L Breast Implant
Study Arms  ICMJE
  • 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
    Intervention: Device: Mentor Larger Size MemoryGel Ultra High Profile 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
    Intervention: Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2017)
400
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2016)
600
Estimated Study Completion Date  ICMJE January 31, 2029
Estimated Primary Completion Date January 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02724371
Other Study ID Numbers  ICMJE MEN-15-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mentor Worldwide, LLC
Study Sponsor  ICMJE Mentor Worldwide, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Canady, M.D. Mentor Worldwide, LLC
PRS Account Mentor Worldwide, LLC
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP