PROspect Registry :Post Market Clinical Follow-up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of care treatment.
- Who it may be relevant to
- Registry conditions: Breast Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)
Overview
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
Interventions
- Device Standard of care treatment
Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Primary outcome measures
- Successful marker localization [Time frame: From the start of surgery to completion of surgery for each participant (assessed intraoperatively, up to the duration of the surgical procedure, typically within the same day)]
- Marker retrieval success [Time frame: From the start of surgery to completion of surgery for each participant (assessed intraoperatively, up to the duration of the surgical procedure, typically within the same day)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Tufts Medical Center — Boston
Identifiers
NCT: NCT07631468 · ENDO-SYK-2025-02_PROSPECT