Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction (NCT07516483)
Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy and breast reconstruction.
Who can join: Review the eligibility criteria below.
Location: Wake Forest University Health Sciences — Winston-Salem, North Carolina
Age range: 18 Years
🧪 Interventions in This Study
- 1 Cycle Thermal Preconditioning (OTHER)
- 3 Cycles Thermal Preconditioning (OTHER)
- No Intervention (OTHER)
📋 "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)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina
📞 Contact the Study Coordinator
Phone: (336) 713-4339
Email: caleb.suggs@advocatehealth.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.
Explore by condition: All Breast Reconstruction After Mastectomy clinical trials
💡 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.