NCT07631468Recruiting
PROspect Registry :Post Market Clinical Follow-up Study
Stryker Endoscopy
Start Date
6/1/2026
Completion Date
12/1/2031
Summary
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Detailed 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 Criteria
Age Range: 18 years to No maximum
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
DEVICE
Standard of care treatment
Conditions
Breast Surgery
Locations
MD Baptist MD Anderson
Jacksonville, Florida 32207
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States