Clinical trials: Device Replacement, active
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
- Conditions
- Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction
- Trial name
- NCT06311331
- Testing
- Total Talus Replacement (TTR)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Restor3D
Knee Osteoarthritis
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured…
- Trial name
- NCT06627673
- Testing
- Total Knee Arthroplasty
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Maxx Orthopedics Inc
Total Thyroidectomy, Hyperthyroidism
Evaluation of Levothyroxine Replacement Therapy After Total Thyroidectomy Using a Smart Wristband
The goal of this observational study is to determine whether nighttime heart rate and heart rhythm data collected by a smart wristband can identify under- or over-replacement with levothyroxine before the routine 1-month thyroid…
- Conditions
- Total Thyroidectomy, Hyperthyroidism, Hypothyroidism
- Trial name
- SMART-THY (NCT07733375)
- Testing
- Xiomi Smart Band 10
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Yeditepe University Hospital
Total Knee Replacement, Orthopedics
TRabecular Metal Economic and Clinical Knee Trial
To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economic implications of using…
- Trial name
- TRECK (NCT04677907)
- Testing
- Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis, Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis
- Where
- United Kingdom
- Volunteers
- 144 people
- Sponsor
- NHS Greater Glasgow and Clyde
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Endocarditis, Bacterial
New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard…
- Trial name
- POET-PPM (NCT06250985)
- Testing
- Timing of reimplantation
- Where
- 5 sites in Denmark
- Volunteers
- 176 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Osteo Arthritis Knee, Knee Arthritis
Persona IQ Cohort Study
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative…
- Conditions
- Osteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty
- Trial name
- NCT06089291
- Testing
- Persona IQ
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
AORTIC VALVE DISEASES, Valve-in-valve Procedures
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic…
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Trial name
- REVIVAL (NCT07524595)
- Testing
- Hydra THV Series, Sapien THV Series and MyVal THV Series
- Where
- Ireland
- Volunteers
- 111 people
- Sponsor
- National University of Ireland, Galway, Ireland
Urinary Urge Incontinence
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
- Trial name
- NCT07383688
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neuspera Medical, Inc.
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
Knee Disease
Study Conducted on Patients Operated With a FHK ASYMETRIQUE to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when…
- Trial name
- NCT04221581
- Testing
- Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis
- Where
- 3 sites in France
- Volunteers
- 43 people
- Sponsor
- FH ORTHO
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
Aortic Valve Stenosis, Aortic Stenosis
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Trial name
- NCT07276711
- Testing
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Where
- 7 sites in United States
- Volunteers
- 663 people
- Sponsor
- EmStop Inc
Device Replacement
A Comparative Study of Portable Patch-type Carotid Ultrasound CADFlow and Desktop Ultrasound Machines
observational study The purpose of this observational study is to clarify the consistency, accuracy, and reproducibility of portable patch carotid ultrasound (CADFlow) compared to desktop ultrasound machines in detecting cardiac…
- Trial name
- NCT07197411
- Testing
- Evaluating the Consistency and Accuracy of Two Devices in Monitoring Hemodynamic Parameters, Hemodynamic monitoring
- Where
- China
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Xuzhou Medical University Affiliated Suqian Hospital
Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- GUARDIAN (NCT06962371)
- Testing
- cerebral embolic protection
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Transverse Medical, Inc.
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency
TRISCEND II Pivotal Trial
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- NCT04482062
- Testing
- Edwards EVOQUE System, Optimal Medical Therapy
- Where
- 62 sites in United States, Germany
- Volunteers
- 864 people
- Sponsor
- Edwards Lifesciences
Aortic Aneurysm, Aortic Aneurysm and Dissection
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic
- Trial name
- RAPID (NCT07078383)
- Testing
- Rapidlink
- Where
- 21 sites in United States, Austria and 3 more
- Volunteers
- 150 people
- Sponsor
- Vascutek Ltd.
Arthrosis, Ankle Arthritis
Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.
On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use.
- Conditions
- Arthrosis, Ankle Arthritis, Ankle Replacement
- Trial name
- NCT07569848
- Where
- Italy
- Volunteers
- 26 people
- Sponsor
- Istituto Ortopedico Rizzoli
Coronary Artery Bypass, Coronary Artery Bypass Graft
A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.
The main goal of this study is to see if a wearable device can reliably track changes in lactate levels in the body. We\'ll compare the device\'s readings to standard blood tests to ensure accuracy.
- Conditions
- Coronary Artery Bypass, Coronary Artery Bypass Graft, Coronary Artery Bypass Graft Surgery (CABG), Valve Replacement
- Trial name
- CONTINUUM LINT (NCT06602336)
- Testing
- Continuous Lactate Monitoring Device
- Where
- United Kingdom
- Volunteers
- 61 people
- Sponsor
- Queen Mary University of London