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New treatment option for Upper Extremity Amputee
Official title Peripheral Interfaces in Amputees for Sensorimotor Integration
ClinicalTrials.gov ID: NCT04430218
What this study is testing
- What it's testing
- The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Acquired upper limb amputation
- Unilateral or bilateral amputation, above or below elbow
- At least 6 months since time of amputation
- Current user of a myoelectric prosthesis or prescribed to use one
- Viable target nerves in the upper extremity
You likely can't join if
- A contraindication preventing surgery
- Uncontrolled diabetes
- Chronic skin ulcerations
- History of poor wound healing without specific cause
- History of uncontrolled infection without specific cause
- Active infection
See the full eligibility criteria
- Acquired upper limb amputation
- Unilateral or bilateral amputation, above or below elbow
- At least 6 months since time of amputation
- Current user of a myoelectric prosthesis or prescribed to use one
- Viable target nerves in the upper extremity
- Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
- A contraindication preventing surgery
- Uncontrolled diabetes
- Chronic skin ulcerations
- History of poor wound healing without specific cause
- History of uncontrolled infection without specific cause
- Active infection
- Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study
- Inability to speak English
- Expectation that MRI will be required at any point for duration of study or while device is implanted.
- Arthritis in the area of implant
- Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
- Presence of auto immune diseases, or conditions requiring immunosuppression.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.