Actively Recruiting
Transdermal Compress IDE Study
Led by Balmoral Medical company · Updated on 2026-05-12
100
Participants Needed
9
Research Sites
363 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
CONDITIONS
Official Title
Transdermal Compress IDE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide written informed consent
- Male or female aged 18 to 60 years (participants under 22 need X-ray confirmation of skeletal maturity)
- Body mass index between 18.5 and 40 kg/m2 and weight 245 lbs or less without prosthesis
- Have unilateral or bilateral transfemoral limb loss without bone or vascular disease
- Have problems with or inability to use conventional prostheses or expected problems with socket prostheses
- Have enough bone to support the implanted device
- No cortical defects between the anchor plug and bone interface
- Willing and able to participate in all study evaluations and rehabilitation program
You will not qualify if you...
- Female who is pregnant, nursing, or planning pregnancy during first 12 months after implantation
- Prior osseointegrated device implanted in the limb planned for study device
- History of infection at residual limb site within 6 months before implantation
- Any distant infections
- History of sepsis within 6 months before implantation
- Residual femur length too short for device insertion
- Femoral deformity preventing proper device insertion or causing poor alignment
- Inadequate myofascial flap for device contact
- History or evidence of severe peripheral vascular disease, muscular atrophy, neuromuscular disease, or diabetes
- History or evidence of osteomyelitis (except below amputation site), osteoporosis, or osteomalacia
- Risk factors for osteoporosis with T-score below -2.5 within 6 months before implantation
- Severe metabolic disorders affecting bone formation
- History of corticosteroid, immunosuppressive, immunomodulatory, or chemotherapy use
- Known drug or alcohol dependence currently or within past year
- Current or recent (past 6 months) use of nicotine or tobacco products
- Other conditions that prevent participation or compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
4
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Walter Reed Military Medical Center
Bethesda, Maryland, United States, 20889
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
8
Penn Medicine; University of Pennsylvania Health System
Philidelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
M
Mary Thacker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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