PROspect Registry :Post Market Clinical Follow-up Study
Purpose
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Condition
- Breast Surgery
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Breast Surgical Procedures | Patients who have undergone breast surgical procedure (per product indications for use) using the Stryker device who meet all of the following criteria will be screened and enrolled by participating Investigators. |
|
Recruiting Locations
MD Baptist MD Anderson
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Contact:
Mona Janfaza PI, MD
Mona Janfaza PI, MD
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
More Details
- Status
- Recruiting
- Sponsor
- Stryker Endoscopy
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