Memory Gel and Shape Combined Cohort (NCT02919592) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Memory Gel and Shape Combined Cohort
United States3,603 participantsStarted 2016-09-01
Plain-language summary
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or revisional breast reconstruction.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. Signs an Acknowledgement of Informed Decision from the patient brochure, or equivalent documentation of discussion and acknowledgement;
✓. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;
✓. Agrees to answer baseline questions;
✓. Agrees to authorize return of the device(s) to Mentor if the device is explanted during study participation;
✓. Agrees via Informed Consent to comply with study follow-up, including following the surgeon's standard of care for office visits and responding to questionnaires in their entirety; and
✓. Has a valid e-mail address and access to the internet to complete online questionnaires.
Exclusion criteria
✕. Has active infection anywhere in her body;
✕. For augmentation patients, has a history of cancer of any kind, except non-melanoma skin cancer; for reconstruction patients, has a history of cancer of any kind, except non melanoma skin cancer or adequately treated breast cancer;
✕. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is currently being evaluated for symptoms suggestive of connective tissue disease or neurological disease;
What they're measuring
1
10 Year Kaplan-Meier estimated cumulative incidence rate of occurrence of local complications
✕. Is planning on undergoing or has undergone bariatric surgery; or
✕. Is planning on undergoing experimental procedures or procedures with investigational products/devices during the study period that in the opinion of the investigator could compromise the results of this study.
✕. Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone or saline implants) and is at least 22 years of age;
✕. Signs an Informed Consent Form, including an Authorization to Disclose Health Information and Release Medical Records;