PROspect Registry :Post Market Clinical Follow-up Study

A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07631468

Enrollment

5000

Registered

2026-06-08

Start date

2026-06-01

Completion date

2031-12-01

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Surgery

Keywords

Breast surgery

Brief 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

Interventions

DEVICEStandard of care treatment

Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

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

Design outcomes

Primary

Measure	Time frame	Description
Successful marker localization	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)	(proportion of MOLLI markers that are detected intraoperatively)
Marker retrieval success	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)	(proportion of procedures in which the MOLLI marker is removed within the surgical specimen)

Countries

United States

Contacts

CONTACTPrajakta Sawwalakhe, MD

prajakta.sawwalakhe@stryker.com16692077970

CONTACTColleen Roden

colleen.roden@stryker.com9312672041

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026