PROspect Registry :Post Market Clinical Follow-up Study
ConditionBreast Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Endoscopy
About this trial
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Standard of care treatment
DeviceSubject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Breast Surgical Procedures1 intervention
Trial outcomes
Primary outcomes
1
Successful marker localization
(proportion of MOLLI markers that are detected intraoperatively)
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)2
Marker retrieval success
(proportion of procedures in which the MOLLI marker is removed within the surgical specimen)
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov