Clinical trials: Prosthetic
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Amputation
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.
- Trial name
- NCT02864693
- Testing
- Kinnex, Pacifica LP
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ability Prosthetics and Orthotics, Inc.
Larynx Cancer
Clinical Feasibility of New Tracheoesophageal Puncture Set
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again.
- Trial name
- NCT01045057
- Testing
- Puncture Set and Flexible Protector
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 27 people
- Sponsor
- Atos Medical AB
Prosthetic Joint Infection (PJI)
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with…
- Trial name
- NCT07858916
- Testing
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection, Oral antibiotics
- Where
- China
- Volunteers
- 40 people
- Sponsor
- TenNor Therapeutics (Zhongshan) Limited
Evaluation of a New Prosthetic Socket Liner Material
Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study II
The purpose of this study is to work with prosthetists to fit the novel conformable socket material developed by Infoscitex, to subjects, and determine if it is a viable alternative to current prosthetic socket liners.
- Trial name
- NCT01455324
- Testing
- Novel conformable woven inner socket
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Infoscitex Corporation
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
Transtibial Amputee, Transtibial Amputation
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
- Trial name
- NCT07195461
- Testing
- Magnetic Bead Tracking System
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MuscleMetrix, LLC
Dental Prosthesis
Observational Study Evaluating Safety and Performance of IDI Dental Implant Systems in Subjects Followed for 18 Months.
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
- Trial name
- NCT05130996
- Testing
- dental prothesis
- Where
- France
- Volunteers
- 121 people
- Sponsor
- Implants Diffusion International
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Prosthetic-joint Infection
A Second Trial of the Abbreviated Protocol Two-Stage Exchange
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm.
- Trial name
- Apex-2 (NCT05607030)
- Testing
- VT-X7 Treatment System, Two-stage exchange arthroplasty, SOC Antibiotics
- Where
- 19 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Prosthetic Joint Infection
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
- Trial name
- ACTIVE2 (NCT05269134)
- Testing
- Bacteriophage
- Where
- 10 sites in United States
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Marginal Bone Level Change
A Clinical Study on Implants With TiUltra Technology and Associated Prosthetic Components
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30…
- Trial name
- NCT04737421
- Testing
- NobelActive TiUltra implant, NobelParallel CC TiUltra implants, NobelReplace CC TiUltra implants
- Where
- 32 sites in United States, Australia and 12 more
- Volunteers
- 1,000 people
- Sponsor
- Nobel Biocare
Infection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee…
- Trial name
- NCT02266407
- Testing
- Aquamantys System
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Blindness
A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind
The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are…
- Trial name
- NCT01488786
- Testing
- BrainPort Vision Device
- Where
- 7 sites in United States, Canada
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Wicab
Refractory Bone or Joint Infections
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
- Trial name
- NCT02569541
- Testing
- sodium fusidate
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Arrevus Inc.
Amputation, Amputation, Traumatic
Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control
The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years…
- Conditions
- Amputation, Amputation, Traumatic, Amputation, Congenital, Prosthesis User
- Trial name
- NCT07011420
- Testing
- Experimental socket with 4 untargeted channels active, Experimental socket with 8 untargeted channels active, Experimental socket with up to 16 untargeted channels active
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, Inc.
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Prosthesis User, Amputation
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of…
- Trial name
- NCT05870267
- Testing
- Power Knee with bone anchored suspension, C-Leg, Rheo Knee XC
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- YourResearchProject Pty Ltd