Post-market follow-up: Breast surgery outcomes with Stryker devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, multi-center observational registry that uses data from standard clinical care to document outcomes after breast procedures performed with MOLLI, SPY-PHI, or SPY AGENT GREEN. The study gathers clinical outcomes and patient-reported outcomes where applicable, focusing on safety and performance of the devices in routine practice. Data come from chart reviews and existing medical records, without any additional interventions beyond standard care. Eligible participants are adults who had breast surgery with the specified Stryker devices, with follow-up occurring at least one month post-procedure. The initiative helps characterize real-world safety signals and patient experiences related to these devices.

Why it matters

Who can join: the full rules

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

Where it's running

• MD Baptist MD Anderson
  Jacksonville, Florida, United States Recruiting
• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Prajakta Sawwalakhe, MD
• Email: prajakta.sawwalakhe@stryker.com
• Phone: 16692077970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.