PROspect Registry :Post Market Clinical Follow-up Study
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Stryker Endoscopy
- Study ID
- NCT07631468
- Status
- Not Yet Recruiting
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Conditions
- Breast Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Standard of care treatment — DEVICESubject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria
Study Details
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- Jun 2026
- Primary completion
- May 1, 2031
- Completion
- Dec 1, 2031
Study Design
- Enrollment
- 5,000 participants (estimated)
Arms
- Arm: Breast Surgical ProceduresPatients 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.
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) ]
Central Contacts
- Prajakta Sawwalakhe, MD16692077970
- Colleen Roden9312672041
Locations (1)
| Facility | City | State | ZIP |
|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 |
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