🏛️ Verified NIH Record • Updated 2026-07-10
A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia (NCT05934851)
A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia
🔵 Active, Not Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: Wake Forest University Health Sciences
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.
Who can join: Review the eligibility criteria below.
Location: Levine Cancer Institute — Charlotte, North Carolina
Age range: 18 Years
🧪 Interventions in This Study
- Frozen-Section Directed Excision (PROCEDURE)
- Wide Local Excision (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)
- Levine Cancer Institute — Charlotte, North Carolina
💰 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.
Explore by condition: All Vulvar Neoplasm clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.