PROspect Registry :Post Market Clinical… | Clinical Trial

Key information

Conditions

Breast Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MD Baptist MD Anderson, Jacksonville, Florida, United States

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care treatment

Device

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

Primary outcomes

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)

(proportion of MOLLI markers that are detected intraoperatively)
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)

(proportion of procedures in which the MOLLI marker is removed within the surgical specimen)

Study contacts

Contact information is provided by the study sponsor or research team.

Colleen Roden

CONTACT

[email protected]

9312672041

Prajakta Sawwalakhe, MD

CONTACT

[email protected]

16692077970

Sponsors and collaborators

Lead sponsor

Stryker Endoscopy

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Jun 8, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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