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(for at least one location)
Rochester, MN
Describes the nature of a clinical study. Types include:
The purpose of this study is to demonstrate the safety and effectiveness of the Melodi Absorbable Antibacterial Matrix for soft tissue support in immediate, two-stage postmastectomy alloplastic prepectoral breast reconstruction, to support an FDA Premarket Approval (PMA) Application.
Study statuses change often. Please contact us for help.
Open for enrollment
Scottsdale/Phoenix, AZ, Jacksonville, FL
This record is for the Prospective treatment arm, the Retrospective cohort will have a seperate protocol and IRBe record.
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Retrospective Arm.
Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN
The purpose of this study is to assess outcomes, satisfaction and aesthetics of two different breast reconstruction techniques (Goldilocks alone, and Goldilocks with Implant-Based Reconstruction) and compare its safety, patient satisfaction, aesthetic evaluation and complications.
Contact us for the latest status
The purpose of this study is to determine whether administration of Topical Transexamic Acid (TXA) at the time of tissue expander placement in the setting of implant-based breast reconstruction reduces postoperative drain volume, as well as reducing the time until drains meet criteria for removal.
In the light of the pandemic, institutions have had to take greater precautions and instigate procedures to aim to improve safety and reduce risk for patients undergoing surgery. One intiative was designed to implement a same day discharge for patients undergoing mastectomy with or without alloplastic reconstruction. This study aims to evaluate the outcomes and patient satisfaction with same day mastectomy with or without alloplastic reconstruction following COVID-19 and compare satisfaction and outcomes (e.g complications) with patients pre-COVID 19. This is part of a quality improvement project.