Transdermal Compress IDE Study

Conditions

• Prosthesis and Implants

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Transdermal Compress Device — 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.

Study Details

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

Key Dates

Start date

Jun 11, 2024

Status verified

May 2026

Primary completion

Dec 31, 2030

Completion

Jun 30, 2031

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Transdermal Compress Device
  The Transdermal Compress device is a bone-anchored transdermal implant that addresses the shortcomings of a socket prosthesis and provides options to amputees who are not able to utilize a conventional socket prosthesis.

Primary Outcome Measure

The study primary endpoint is a composite endpoint to determine the proportion of participants who are successful on the primary effectiveness and safety endpoints (overall success) at 2 years [ Time Frame: Two (2) years post-implantation ]

Central Contacts

• Mary Thacker
  1-978-760-3826
  [email protected]

Locations (9)

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