A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)
Stryker Endoscopy
Summary
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Description
The purpose of this study is to leverage standard of care data on clinical outcomes following surgical procedures as indicated for each device. * Performance Objective: To collect clinical outcomes and Patient Reported Outcome Measures (PROMs) data (as applicable) on subjects that have undergone surgical breast procedures utilizing one or more Stryker devices. * Safety Objective: To collect data on safety events on the use of Stryker devices and/or related procedures
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: * Subject was ≥ 18 years of age at the time of the surgery * Patients who have undergone breast surgical procedures using MOLLI, SPY-PHI, and/or SPY AGENT GREEN Exclusion Criteria: * Subjects who are less than 1-month post-intervention * Concurrent participation in an interventional investigational clinical study at the time of initial surgery * Subjects whose surgery date was prior to January 2022. * Pregnant or lactating females at the time of initial surgery
Interventions
- DeviceStandard of care treatment
Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Location
- Tufts Medical CenterBoston, Massachusetts