Clinical trials: Device Replacement
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.
Acute Renal Failure
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal failure (ARF).
- Trial name
- NCT01072682
- Testing
- Selective cytopheretic device (SCD)
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- SeaStar Medical
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
Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System…
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- Trial name
- COC36mmPAS (NCT02096198)
- Where
- 5 sites in United States
- Volunteers
- 81 people
- Sponsor
- DePuy Orthopaedics
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
Osteoarthritis, Total Knee Arthroplasty
Use of Cold and Compression Therapy With Total Knee Replacement Patients
The purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.
- Trial name
- NCT00712816
- Testing
- Game Ready Injury Treatment System (CoolSystems Inc.), Ice with compressive bandages
- Where
- 11 sites in United States, Australia
- Volunteers
- 224 people
- Sponsor
- CoolSystems, Inc.
Deep Vein Thrombosis
Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.
- Trial name
- NCT01935414
- Testing
- geko™ post-surgery for 48hrs then 4hrs/day until discharge., TEDS post-surgery for 48hrs then 4hrs/day until discharge.
- Where
- United Kingdom
- Volunteers
- 72 people
- Sponsor
- Firstkind Ltd
Chronic Low Back Pain, Lumbar Degenerative Disc Disease
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients…
- Trial name
- DISCERN (NCT00949936)
- Testing
- CAdisc™-L (Total Disc Replacement)
- Where
- 4 sites in Belgium, Germany and 2 more
- Sponsor
- Ranier Technology Limited
Bleeding, Bypass Complication
A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding.
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Trial name
- NCT05542277
- Testing
- ClearPlasma
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 130 people
- Sponsor
- PlasFree Ltd.
Osteoarthritis, Post-Traumatic Arthritis
Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
- Conditions
- Osteoarthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT00586781
- Testing
- Scandinavian Total Ankle Replacement (STAR)
- Where
- 5 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Link America, Inc.
Lumbar Spine Degeneration
MOTUS Total Joint Replacement Investigational Device Exemption Study
This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate…
- Trial name
- NCT05438719
- Testing
- MOTUS Total Joint Replacement
- Where
- 14 sites in United States
- Volunteers
- 158 people
- Sponsor
- 3Spine
Smoking
Clinical Study of Smoke-Break Liquid Cigarettes
The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.
- Trial name
- NCT00715871
- Testing
- Nicotine, Smoke-Break nicotine delivery device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Smoke-Break, Inc.
Aortic Aneurysm, Aortic Dissection
Thoraflex™ Hybrid IDE Study
The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of…
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Rupture
- Trial name
- NCT02724072
- Testing
- Thoraflex™ Hybrid Device
- Where
- 12 sites in United States
- Volunteers
- 84 people
- Sponsor
- Bolton Medical
Heart Failure
Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair
The purpose of this study to evaluate patients when they have an Acorn CorCapTM Cardiac Support Device (CSD) placed around their heart for the treatment of heart failure at the same time as their mitral valve surgery.
- Trial name
- MVR + CorCap (NCT00630266)
- Testing
- CorCap CSD
- Where
- 12 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Acorn Cardiovascular, Inc.
Acute Coronary Syndrome
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine…
- Trial name
- CyTation (NCT04625764)
- Testing
- Blood sampling and analysis
- Where
- 4 sites in Germany, Luxembourg
- Volunteers
- 6 people
- Sponsor
- CytoSorbents Europe GmbH
Degenerative Disc Disease, Chronic Low-back Pain
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
- Trial name
- NCT04004156
- Testing
- PerQdisc® Nucleus Replacement Device.
- Where
- 4 sites in Belgium, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- Spinal Stabilization Technologies
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
Acute Kidney Injury
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI)…
- Trial name
- NEUTRALIZE-AKI (NCT05758077)
- Testing
- Selective Cytopheretic Device, Standard of Care
- Where
- 36 sites in United States
- Volunteers
- 339 people
- Sponsor
- SeaStar Medical
Arthroplasty, Replacement, Knee
ZIPS Study - Zip Incision Approximation vs. STAPLE
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
- Trial name
- ZIPS (NCT02255877)
- Testing
- Zip Surgical Skin Closure, Steel Staples
- Where
- United States
- Sponsor
- ZipLine Medical Inc.
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.