NCT06134167

A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants With Transfemoral Amputations

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Balmoral Medical company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a prospective, multicenter, single-arm, open-label study in skeletally mature participants with transfemoral limb loss (unilateral or bilateral), without bone or vascular disease who have or are anticipated to have rehabilitation problems with or cannot use a conventional socket prosthesis. Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1. Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol. Events of special interest include superficial and deep infections at the implant site, failures, and secondary surgical interventions; participants will be followed for all soft tissue interface issues. Participants will be assessed for effectiveness and safety endpoints at baseline and at Months 6, 12, 18, and 24 and annually through 5 years post-implantation. Adverse events and adverse device effects will be collected and reported starting at the time of surgical implantation. Study participants will also be included in the Osseointegration Quality Registry in parallel to this study to allow for long-term follow-up post-study.

Conditions

• Prosthesis and Implants

Interventions

Type	Name	Description
DEVICE	Transdermal Compress Device	Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1. Participants will be followed through the end of the study as they complete rehabilitation.

Timeline

• Start date: 2024-06-11
• Primary completion: 2030-12-01
• Completion: 2031-06-01
• First posted: 2023-11-18
• Last updated: 2026-04-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study