Prosthesis and ImplantsNCT06134167
Transdermal Compress IDE Study
A study testing Transdermal Compress Device in people with Prosthesis and Implants, run by Balmoral Medical company at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prosthesis and Implants
- What is being tested?
- Transdermal Compress Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Jun 2024to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any study-specific procedures.
- Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Participants < 22 years of age require radiographic confirmation of skeletal maturity and must have failed the use of conventional prosthesis.
- Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
- Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
- Participant has problems with conventional prostheses or is not able to use a prosthesis at all or is anticipated to experience problems with a socket prosthesis in the investigator's judgment.
- Participant has adequate bone stock to support the implanted device
- Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
- Participant has the willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
Who cannot join
- Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
- Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
- Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
- Participant has any distant foci of infections.
- Participant has a history of sepsis within 6 months prior to Study Day 1.
- Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
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- Participant has a femoral deformity that in the opinion of the treating surgeon results in an inability to properly insert the Transdermal Compress implant system, and/or results in alignment that is biomechanically unsound.
- Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.
- Participant has evidence of or history of severe peripheral vascular disease or insufficiency, muscular atrophy, neuromuscular disease, or diabetes mellitus (Type I or Type II).
- Participant has evidence of or a documented history of osteomyelitis (excluding the history of osteomyelitis distal to amputation), systemic osteoporosis, or osteomalacia.
- Participants with identified risk factors for osteoporosis must have a reported T-score > -2.5 within 6 months prior to Study Day 1.
- Participant has evidence of or a documented history of severe metabolic disorders that may impair bone formation.
- Participant has a history of systemically administered corticosteroids or immunosuppressive or immunomodulatory therapy or chemotherapy drugs.
- Participant has known drug or alcohol dependence currently or within the last year.
- Participant is a smoker, nicotine, or tobacco user in any form or who has used nicotine or tobacco-containing products within the past 6 months prior to Study Day 1.
- Participant has any other condition, which in the opinion of the Investigator, precludes the participant's participation in the study or the participant is unlikely to comply with the protocol-defined
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
J Stoneback, MD
Eric Earley, 303-724-4089, LimbRestoration@uchealth.org
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
V Laljani, 410-502-2160, vparikh2@jhmi.edu
M Hamilton-Hall, 203-219-1636, mhamil39@jh.edu
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Q Liu, 240-645-3068, Qingfeng.liu.ctr@usuhs.edu
Emma Stewart, 202-549-3229, emma.l.stewart4.ctr@health.mil
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
L Hrvojevic, 312-695-4463, lidia.hrvojevic@nm.org
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
J Souza, MD, 614-293-8566, nervenerds@osumc.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
J Forsberg, MD, 212-639-2076, forsbej@mskcc.org
- Recruiting
Penn Medicine; University of Pennsylvania Health System
Philidelphia, Pennsylvania, 19104
W Harding, 484-802-9675, warren.harding@pennmedicine.upenn.edu
B Potter, MD, 215-294-9667, benjamin.potter@pennmedicine.upenn.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
R McGough, MD, 412-802-4100, mcgoughrl@upmc.edu
B Krawczyk, 412-605-3003, krawbx@upmc.edu
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
M Arnold, 916-734-6935, mesalvador@health.ucdavis.edu
About this study
Official title: A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
Read the 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
- Being tested
- Transdermal Compress Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Compress DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Transdermal Compress Device | Experimental | 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. Receives: Device: Transdermal Compress Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The following endpoint components will be used to assess effectiveness in the composite endpoint:
Prosthetic Wear Time PROMIS Physical Function OPUS Satisfaction with Devices and Services
The following will be used to assess safety in the composite endpoint:
Lack of secondary surgical intervention. No more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
Radiographic success.
Measured: Two (2) years post-implantation
Secondary outcomes (12)
Overall infection rate
Overall infection rate subclassified as deep or superficial to the fascia.
Measured: Two (2) and Five (5) years post-implantation
Lack of secondary surgical intervention
Lack of secondary surgical intervention
Measured: Two (2) and Five (5) years post-implantation
Orthotics and Prosthetics Users Survey: Satisfaction with Devices
21-item scale that measures satisfaction with the prosthetic device and care quality. Items are rated on 5 points (1 = Strongly agree to 5 = Strongly Disagree).
Measured: Two and Five (2-5) years post-implantation
Prosthetic Wear Time
Prosthetic Wear Time- Hours per Day.
Measured: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Physical Function
Clinical outcome assessment (COA) that measures the patient's experience with the use of a transdermal device in that the primary goal is to improve physical function.: Physical Function. Items on are rated on 5 points (1 = unable to do. 5 = Without any difficulty).
Measured: Two (2) and Five (5) years post-implantation
A composite endpoint will be evaluated to determine the proportion of participants who are successes on both the primary effectiveness and safety endpoints at 2 years and 5 years.
The following endpoint components will be used to assess effectiveness in the composite endpoint:
Prosthetic Wear Time Patient Reported Outcome Measurement Information System: Physical Function Orthotics and Prosthetics Users Survey: Satisfaction with Devices
Measured: Two (2) and Five (5) years post-implantation
The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
Measured: Two (2) years post-implantation
The proportion of participants who have had serious device-related adverse events.
The proportion of participants who have had serious device-related adverse events.
Measured: Two (2) and Five (5) years post-implantation
Type and frequency of mechanical complications over time.
Any mechanical complications will be recorded and evaluated for device deficiencies.
Measured: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Intensity
Pain Intensity domain measures self-reported pain on a scale of 0 (No Pain) to 10 (Worst imaginable pain).
Measured: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Behavior
Measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.
Measured: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Interference
They include observable displays (sighing, crying), pain severity behaviors (resting, guarding, facial expressions, and asking for help), and verbal reports of pain. The scale contains 7-question rating to evaluate pain behavior on a 6 point scale (1 = Had no pain, 6 = Always have pain
Measured: Two (2) and Five (5) years post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Jun 2024
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis and ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balmoral Medical company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Recker, M.D., Study director, Balmoral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134167
- Sponsor's protocol ID
- BAL-448-001
- Status last verified
- May 2026
- First submitted
- 18 Oct 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations
- ClinicalTrials.gov ID
- NCT06134167
- Acronym / sponsor ID
- BAL-448-001
- Conditions
- Prosthesis and Implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Balmoral Medical companyIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transdermal Compress Device | Experimental | Device: Transdermal Compress DeviceThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any study-specific procedures.
- Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Participants < 22 years of age require radiographic confirmation of skeletal maturity and must have failed the use of conventional prosthesis.
- Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
- Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
- Participant has problems with conventional prostheses or is not able to use a prosthesis at all or is anticipated to experience problems with a socket prosthesis in the investigator's judgment.
Key exclusion criteria (16 listed)
- Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
- Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
- Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
- Participant has any distant foci of infections.
- Participant has a history of sepsis within 6 months prior to Study Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Compress DeviceStudy 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. | Device | Transdermal Compress Device |
Primary outcome
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
The following endpoint components will be used to assess effectiveness in the composite endpoint: Prosthetic Wear Time PROMIS Physical Function OPUS Satisfaction with Devices and Services The following will be used to assess safety in the composite endpoint: Lack of secondary surgical intervention. No more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation. Radiographic success.
12 secondary outcomes
Overall infection rate
Time frame: Two (2) and Five (5) years post-implantation
Lack of secondary surgical intervention
Time frame: Two (2) and Five (5) years post-implantation
Orthotics and Prosthetics Users Survey: Satisfaction with Devices
Time frame: Two and Five (2-5) years post-implantation
Prosthetic Wear Time
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Physical Function
Time frame: Two (2) and Five (5) years post-implantation
A composite endpoint will be evaluated to determine the proportion of participants who are successes on both the primary effectiveness and safety endpoints at 2 years and 5 years.
Time frame: Two (2) and Five (5) years post-implantation
The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
Time frame: Two (2) years post-implantation
The proportion of participants who have had serious device-related adverse events.
Time frame: Two (2) and Five (5) years post-implantation
Type and frequency of mechanical complications over time.
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Intensity
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Behavior
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Interference
Time frame: Two (2) and Five (5) years post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Recker, M.D. study director
Balmoral
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal Compress Device in people with Prosthesis and Implants, run by Balmoral Medical company at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Thacker (1-978-760-3826, BAL-448-001@capstonedevservices.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.