Recruiting

Observational Study

Sponsor:

Stryker Endoscopy

Code:

NCT07631468

Conditions

Breast Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of care treatment

Study Details

Brief summary:

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

Conditions

Breast Surgery

Study ID

NCT07631468

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 1, 2031

Anticipated

Primary completion date

May 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Standard of care treatment

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

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Prajakta Sawwalakhe, MD

16692077970prajakta.sawwalakhe@stryker.com

Colleen Roden

9312672041colleen.roden@stryker.com

Locations

MD Baptist MD Anderson

Recruiting

Jacksonville, Florida, United States, 32207

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Sarah Persing Principle Investigator, MD

sarah.persing1@tuftsmedicine.org

More Information

Sponsor

Stryker Endoscopy

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Breast surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stryker Endoscopy on 2026-08-19.