Status:
WITHDRAWN
EFS Functional Expectations of Transhumeral Percutaneous OI Patients
Lead Sponsor:
VA Office of Research and Development
Conditions:
Transhumeral Amputation
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
An FDA Early Feasibility Study (EFS) allows for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. The Primary Aim of this proposal is to perform an F...
Detailed Description
An FDA Early Feasibility Study (EFS) allows "for early clinical evaluation of devices to provide proof of principle and initial clinical safety data." Over the past four years, the team has performed ...
Eligibility Criteria
Inclusion
- A subject will be included in the study if he/she meets all of the following criteria:
- Has a unilateral or bilateral transhumeral amputation and is at least 18 years of age
- Has previously used, or is currently using, a prosthesis with a socket-based system
- Is willing, able, and committed to participate in all evaluations for the study
- Can provide IRB approved written informed consent to participate
- Is willing to travel to Salt Lake City, Utah for a 3-day study funded visit
Exclusion
- A subject will be excluded from the study if he/she meets any of these criteria:
- Is pregnant at the time of visit (Excluded due to radiation exposure from CT/DEXA/Xray)
- Is currently receiving renal dialysis
- Has muscular, neurologic, or vascular deficiencies that affect the bone or soft tissue of an affected extremity(ies)
- Has, in the consensus of the investigators, physical limitations or other medical conditions that may prevent the subject from being an appropriate study candidate, i.e.:
- other disease processes
- mental incapacity
- substance abuse (masking pain)
- vulnerable subject population)
- Has cardiac or pulmonary condition limiting functional abilities
- Subject is a prisoner
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03824444
Start Date
January 1 2024
End Date
January 23 2024
Last Update
January 26 2024
Active Locations (1)
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1
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001