The Safety and Effectiveness of DuraSorb for Lower Pole Reinforcement in Patients Undergoing 2 Stage Breast Reconstruction

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The Safety and Effectiveness of DuraSorb for Lower Pole Reinforcement in Patients Undergoing 2 Stage Breast Reconstruction

Brief description of study

The purpose of this research is to test the safety and performance of DuraSorb® mesh when used to support your expander during 2-stage breast reconstruction. DuraSorb® mesh has been cleared by the FDA and is marketed for use in soft tissue support. Using DuraSorb® mesh specifically for 2-stage breast reconstruction is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this device in the current trial.

Clinical Study Identifier: s20-01123

ClinicalTrials.gov Identifier: NCT04646057

Principal Investigator: Mihye Choi.

Other Investigator: Brooke J Miller.

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Perlmutter Cancer Center

Clinical Trials & Research Studies