The Safety and Effectiveness of DuraSorb for Lower Pole Reinforcement in Patients Undergoing 2 Stage Breast Reconstruction
Brief description of study
This is a multi-center, comparative, interventional clinical study to evaluate the safety and effectiveness of DuraSorb® when implanted in subjects undergoing 2- stage breast reconstruction to support the lower pole, vs. matching historical controls with no mesh. Retrospective medical chart reviews of patients who have two-stage breast reconstruction with no mesh will be performed to obtain these matching controls.
Clinical Study Identifier: s20-01123
ClinicalTrials.gov Identifier: NCT04646057
Principal Investigator:
Mihye Choi.
Other Investigator:
Brooke J Miller.
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