PROspect Registry :Post Market Clinical Follow-up Study

Conditions

• Breast Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of care treatment — DEVICE
  Subject 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

First listed

Jun 8, 2026

Start date

Jun 1, 2026

Status verified

Aug 2026

Primary completion

May 1, 2031

Completion

Dec 1, 2031

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: 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.

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, MD
  16692077970
  [email protected]
• Colleen Roden
  9312672041
  [email protected]

Locations (2)

Find similar trials in Jacksonville, FL

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