Breast SurgeryNCT07631468
PROspect Registry :Post Market Clinical Follow-up Study
An observational study of Breast Surgery, run by Stryker Endoscopy at 2 sites in United States.
Trial summary
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Surgery
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2026to 1 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Sarah Persing Principle Investigator, MD, sarah.persing1@tuftsmedicine.org
- Recruiting
MD Baptist MD Anderson
Jacksonville, Florida, 32207
Mona Janfaza PI, MD
About this study
Official title: A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Read the 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
- Conditions
- Breast Surgery
- Being tested
- Standard of care treatment
- Keywords
- Breast surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care treatmentDevice
Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful marker localization
(proportion of MOLLI markers that are detected intraoperatively)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026
- Primary completion1 May 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Stryker Endoscopy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631468
- Sponsor's protocol ID
- ENDO-SYK-2025-02_PROSPECT
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)
- ClinicalTrials.gov ID
- NCT07631468
- Acronym / sponsor ID
- ENDO-SYK-2025-02_PROSPECT
- Conditions
- Breast Surgery
- Keywords
- Breast surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Stryker EndoscopyIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Surgical Procedures | – | Device: Standard of care treatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care treatmentSubject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria | Device | Breast Surgical Procedures |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Surgery, run by Stryker Endoscopy at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prajakta Sawwalakhe, MD (16692077970, prajakta.sawwalakhe@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.