๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-18

Transdermal Compress IDE Study (NCT06134167)

A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Balmoral Medical company

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.

Who can join: Review the eligibility criteria below.

Location: UC Davis Medical Center โ€” Sacramento, California

Age range: 18 Years to 60 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (9 Sites)

  • UC Davis Medical Center โ€” Sacramento, California
  • University of Colorado Anschutz Medical Campus โ€” Aurora, Colorado
  • Northwestern Memorial Hospital โ€” Chicago, Illinois
  • The Johns Hopkins Hospital โ€” Baltimore, Maryland
  • Walter Reed National Military Medical Center โ€” Bethesda, Maryland
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • The Ohio State University Wexner Medical Center โ€” Columbus, Ohio
  • Penn Medicine; University of Pennsylvania Health System โ€” Philidelphia, Pennsylvania
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (978) 760-3826

Email: BAL-448-001@capstonedevservices.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—