Clinical Trials

Plan to conduct a pilot randomized controlled trial to determine the feasibility, benefits and educational impact of using simulation for patient education (SimEd) for post-mastectomy wound and drain care, compared to current patient education practice (StdEd). This study also seeks to derive and validate a skills assessment tool specifically developed to evaluate skills acquired during the education process and compare the results of SimEd vs StdEd; we also plan to relate the scores of our assessment tool to a validated instrument that measures readiness for patient dismissal and compare their results in both study arms.

The purpose of this study is to investigate post operative complications in patients who underwent mastectomy followed by tissue expander reconstruction and were admitted to the Care Hotel for overnight observation compared to the standard hospital admission and those who are discharged home. The secondary intent is to investigate overall patient satisfaction with the Care Hotel Model.​  

The purpose of this registry is to collect and maintain samples of breast tissue from women and men undergoing surgery for a breast related concern at Mayo Clinic Rochester,  to create a biospecimen resource for the study of benign and cancerous breast conditions.

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).

Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).

Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial ...

The purpose of this retrospective study is to evaluate the complication rate of prophylactic open NSM procedures through 42 days follow-up from retrospective chart review at the same investigators and institutions as those included under IDE Study protocol G190065/A001.

The purpose of this study is to culture human mammary cells to identify cellular characteristics associated with lobular involution status. 

The purpose of this study is to estimate the circulating tumor DNA (ctDNA)detection rate and mutational load in breast cancer patients with indications for regional nodal irradiation.

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.

The purpose of this study is to evaluate surgical sterility, the microbiome, and infections post mastectomy with immediate/tissue expander surgery by using OR camera recording, surgical site and/or microbiome analysis.

Researchers at Mayo Clinic are developing a Biobank of adult stem cell-rich breast organoids, a new research resource to facilitate normal and cancer stem cell research. Subjects in the Biobank will provide samples of excess breast tissue, complete a health questionnaire, and allow access to medical records now and in the future. The Biobank serves as a library for researchers; instead of having to look for volunteers for each new project, researchers can use samples from the Biobank as well as share information already collected.

The purpose of this study is to determine what patient or clinical factors are predictive for the choice to have nipple reconstruction or type of nipple reconstruction.

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. 

The purpose of this study is to describe a new surgical technique for nipple reconstruction in female-to-male transgender chest wall reconstruction and demonstrate its safety, patient satisfaction, aesthetic evaluation and complications. Subsequently, correlate these findings to assess overall surgical and clinical outcomes.

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 ...

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.