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Trial record 5 of 28 for:    Recruiting Studies | breast implants

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)

This study is currently recruiting participants.
Verified October 2017 by Mentor Worldwide, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02724371
First Posted: March 31, 2016
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mentor Worldwide, LLC
  Purpose
The study will evaluate the safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.

Condition Intervention
Breast Reconstruction, Revision Breast Reconstruction Device: Mentor Larger Size MemoryGel Ultra High Profile Breast Implant

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Actual Study Start Date: April 1, 2016
Estimated Study Completion Date: September 1, 2026
Estimated Primary Completion Date: September 1, 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: UHP-L Breast Implant

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724371


Contacts
Contact: Andrew Schut 949-923-4135 athena_clinical@its.jnj.com

  Show 29 Study Locations
Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Study Director: John Canady, M.D. Mentor Worldwide, LLC
  More Information

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT02724371     History of Changes
Other Study ID Numbers: MEN-15-001
First Submitted: March 21, 2016
First Posted: March 31, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No