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Sponsored by: |
Mentor Corporation |
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Information provided by: | Mentor Corporation |
ClinicalTrials.gov Identifier: | NCT00756652 |
The U.S. Food and Drug Administration (FDA) recently approved Mentor's MemoryGel™ silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. The postapproval study described in this protocol is intended to satisfy one element of FDA's postapproval monitoring requirements.
Condition |
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Breast Reconstruction Breast Augmentation Breast Revision |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study |
Estimated Enrollment: | 42900 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | July 2018 |
Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Silicone Participants
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2
Saline Participants
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
MemoryGel™ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mentor Corporation ( Rosalyn d'Incelli/Director, Clinical Studies ) |
Study ID Numbers: | P030053 |
Study First Received: | September 18, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00756652 History of Changes |
Health Authority: | United States: Institutional Review Board |