Clinical Trials

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.

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 to determine if neurotization improves patient-reported satisfaction outcomes and improves sensation, compared with nipple sparing mastectomy without neurotization.

1. Primary Objective

To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

2. Secondary Objectives

1. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.

2. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.

3. To determine rate of mastectomy skin flap necrosis following NSM via the SKIN score.

The purpose of this study is to investigate the safety, effectiveness, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by effectiveness that will be assessed from fluorescence imaging observations and data.

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.

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

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

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 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.

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.