Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout® (NCT05825482)
🩺 Plain-English Summary (8th-Grade Level)
This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.
Who can join: Review the eligibility criteria below.
Location: Cleveland Clinic Akron General, Case Comprehensive Cancer Center — Akron, Ohio
Age range: 18 Years
🧪 Interventions in This Study
- Arm 1 Partial mastectomy with Savi Scout® localization and shave margins. (PROCEDURE)
- Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins. (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic Akron General, Case Comprehensive Cancer Center — Akron, Ohio
📞 Contact the Study Coordinator
Phone: (330) 344-6348
Email: catchpw@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.