PROspect Registry :Post Market Clinical Follow-up Study

NCT07631468 · tracked via the Priya Life Science USA tracker

Sponsor

Stryker Endoscopy

Phase

Observational

Started

2026-06-01

Last updated

2026-08-19

Condition(s) studied

Breast Surgery

Investigational drug(s) / intervention(s)

Standard of care treatment

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

Study summary

Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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)

Trial sites (2)

Facility	City	Region	Status
MD Baptist MD Anderson	Jacksonville	Florida	Recruiting
Tufts Medical Center	Boston	Massachusetts	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07631468 on ClinicalTrials.gov ↗ ← All trials in the USA