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Sponsored by: |
LifeCell |
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Information provided by: | LifeCell |
ClinicalTrials.gov Identifier: | NCT00619762 |
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.
Condition | Intervention |
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Mastectomy |
Device: LTM - a porcine-based surgical mesh |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy |
Tissue sample
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Washington, District of Columbia, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, New York | |
Great Neck, New York, United States | |
United States, Pennsylvania | |
Willow Grove, Pennsylvania, United States | |
United States, Virginia | |
McLean, Virginia, United States |
Responsible Party: | LifeCell Corporation ( Janice M. Smiell, MD ) |
Study ID Numbers: | LFC2007.01.01 |
Study First Received: | January 11, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00619762 |
Health Authority: | United States: Institutional Review Board |
Breast reconstruction |