Clinical trials: Upper Limb Amputation
Amputation, Upper Limb
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.
- Trial name
- NCT06539936
- Testing
- Glide, Direct Control
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Infinite Biomedical Technologies
Prostheses, Upper Limb Amputation Below Elbow
Wireless Prosthetic Control Effectiveness Study
The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the Asterisk system, on transradial prosthesis users.
- Trial name
- NCT06821412
- Testing
- ASTERISK System, Wired Configuration
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Liberating Technologies, Inc.
Amputation, Amputation, Traumatic
Evaluation of Dexterous Terminal Device
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper
- Trial name
- NCT05840601
- Testing
- Pointdexter, Comparator
- Sponsor
- Liberating Technologies, Inc.
Amputation, Amputation; Traumatic, Hand
Dexterous Partial Hand Prosthesis Outcomes
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User
- Trial name
- NCT05038566
- Testing
- Pointdexter
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation, Amputation of Lower Limb
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss
- Trial name
- VANISH (NCT06908538)
- Testing
- cryoablation
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- AtriCure, Inc.
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Study on a Prosthetic Foot With Adjustable Heel Height
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an…
- Trial name
- ADJUST (NCT07214493)
- Testing
- Taleo Adjust, The usual participant's foot
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- Otto Bock France SNC
Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation
Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses.
- Conditions
- Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation, Transradial Amputation
- Trial name
- CYBORG (NCT07325708)
- Testing
- Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Phantom Neuro Inc.
Amputation; Traumatic, Arm, Upper
Teleoperation Experimental Comparison With Able-bodied Subjects
To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2).
- Trial name
- NCT05048394
- Testing
- Semi-autonomous myoelectric control algorithm, Standard-of-care myoelectric control algorithm
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Point Designs
Lower Limb Amputation Above Knee (Injury)
New Microprocessor-Controlled Prosthetic Knee Evaluation
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK.
- Trial name
- NCT06017024
- Testing
- microprocessor-controlled knee (MPK) assessment
- Where
- 5 sites in France
- Volunteers
- 18 people
- Sponsor
- Proteor Group
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm: Forearm
Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation
ORTHOPUS develops assistive technologies to address the lack of availability of medical devices in low and middle income countries.
- Conditions
- Amputation; Traumatic, Arm, Upper, Amputation; Traumatic, Arm: Forearm, Amputation; Traumatic, Hand, at Wrist Level, Wounds and Injuries
- Trial name
- NCT04803253
- Testing
- ORTHOPUS prosthetic accessory: 0109 - Universal Wrist, ORTHOPUS prosthetic terminal device: 0112 - Hook, ORTHOPUS prosthetic terminal device: 0105 - Cosmetic Articulated Hand
- Where
- 3 sites in Nepal
- Volunteers
- 14 people
- Sponsor
- Orthopus
Upper Limb Amputation, Transradial Amputation
Cross-Over Study Evaluating the TASKA GEN2 Myoelectric Hand Prosthesis
This prospective multicentre randomized cross-over post-market clinical follow-up study compares the TASKA GEN2 multi-grip myoelectric hand prosthesis with marketed comparator prostheses in adults with upper-limb amputation.
- Conditions
- Upper Limb Amputation, Transradial Amputation, Transhumeral Amputation
- Trial name
- NCT07876115
- Testing
- TASKA GEN2 Multi-Grip Myoelectric Hand Prosthesis, Michelangelo or I-Limb Ultra multi-grip myoelectric prosthesis
- Where
- France
- Volunteers
- 20 people
- Sponsor
- TASKA Prosthetics
Lower Limb Amputation Above Knee (Injury)
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life.
- Trial name
- INCREMENT (NCT06635655)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Proteor Group
Lower Limb Amputation Above Knee (Injury)
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
- Trial name
- P20-EMBSUBI (NCT04791163)
- Testing
- Socket evaluation
- Where
- 9 sites in France
- Volunteers
- 25 people
- Sponsor
- Proteor Group
Amputation, Prosthesis User
Myoelectric Game Training and Outcomes
The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Trial name
- NCT04354493
- Testing
- Myo-electric Gaming Interface
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Upper Limb Amputation Below Elbow (Injury)
Assessment of Gesture Accuracy of a Prosthesis Control System
The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
- Trial name
- ASCENT (NCT06446037)
- Testing
- Non-invasive EMG band instrumentation
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Phantom Neuro Inc.
Upper Limb Amputation Above Elbow, Upper Limb Amputation Below Elbow
Long-Term Stability of the Glide Control Strategy
This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced…
- Trial name
- NCT07222085
- Testing
- Glide Control System, Pattern Recognition System
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- Infinite Biomedical Technologies