Transdermal Compress IDE Study
ConditionProsthesis and Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBalmoral Medical company
About this trial
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Transdermal Compress Device
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov