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)
1 other identifier
observational
5,000
1 country
1
Brief Summary
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
June 8, 2026
June 1, 2026
4.9 years
April 20, 2026
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Successful marker localization
(proportion of MOLLI markers that are detected intraoperatively)
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
(proportion of procedures in which the MOLLI marker is removed within the surgical specimen)
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)
Study Arms (1)
Breast Surgical Procedures
Patients who have undergone breast surgical procedure (per product indications for use) using the Stryker device who meet all of the following criteria will be screened and enrolled by participating Investigators.
Interventions
Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Eligibility Criteria
Patients who have undergone a surgical procedure using the Stryker device(s) who meet all of the eligibility criteria will be screened and enrolled by participating Investigators.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2026
First Posted
June 8, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
May 1, 2031
Study Completion (Estimated)
December 1, 2031
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share