Clinical trials: Device Malfunction
Vascular Access, Vascular Access Complication
Novel Medical Device for Pharmacological Therapy
Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient.
- Conditions
- Vascular Access, Vascular Access Complication, Vascular Access Complications, Catheter Malfunction
- Trial name
- Sechold (NCT06938750)
- Testing
- SECHOLD DEVICE
- Where
- Spain
- Volunteers
- 262 people
- Sponsor
- Fundacion Miguel Servet
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Growth Hormone Deficiency, Turner Syndrome
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age
- Trial name
- NCT00738205
- Volunteers
- 834 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Obstructive Sleep Apnea, Heart Failure
Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea and Its Impact on Cardiac Remodeling
Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced Ejection Fraction (HFrEF) and obstructive sleep…
- Trial name
- MOSAIC (NCT02948894)
- Testing
- Mandibular advancement device
- Where
- 2 sites in Singapore
- Volunteers
- 100 people
- Sponsor
- National University of Singapore
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Cardiomyopathies
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases
- Trial name
- E-Motion (NCT04634708)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Berlin Heart GmbH
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Asthma, Heart Failure
The General Breathing Record Study
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness.
- Conditions
- Asthma, Heart Failure, Pneumonia, Motor Neuron Disease
- Trial name
- GBRS (NCT03356288)
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- TidalSense
Heart Disease, Dyspnea
Influence of Routinely Adding Ultrasound Screening in Medical Department
Ultrasound (US) is widely used as a diagnostic tool in a hospital setting. In a medical department, diagnosis like heart failure or most kinds of heart diseases, hypervolemia, hypovolemia, pleural effusion, pericardial effusion…
- Conditions
- Heart Disease, Dyspnea, Aortic Disease, Kidney Disease
- Trial name
- NCT01331187
- Testing
- Pocket-size ultrasonography, Usual care
- Where
- Norway
- Volunteers
- 600 people
- Sponsor
- Helse Nord-Trøndelag HF
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
T-cell Depleted Alternative Donor Transplantation
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT00968864
- Testing
- CliniMACS® (T cell depletion)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Wake Forest University Health Sciences
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter.
- Trial name
- NCT04559334
- Testing
- Tetrasodium EDTA Catheter Lock Solution
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Children's Hospital
Renal Failure
Non-invasive Determination of Anemia in Children With Renal Failure
Anemia and inflammation are very common in patients with renal diseases. The most common procedure to detect anemia is to determine blood hemoglobin concentrations.
- Trial name
- NCT02369237
- Volunteers
- 54 people
- Sponsor
- Center for Studies of Sensory Impairment, Aging and Metabolism
Heart Failure
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study.
- Trial name
- Microtech-LVAD (NCT06682910)
- Testing
- Microtech sensor pressure
- Where
- 2 sites in United States, Israel
- Volunteers
- 15 people
- Sponsor
- Microtech Medical Technologies, Ltd
Atelectasis, Pulmonary Infection
Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo…
- Conditions
- Atelectasis, Pulmonary Infection, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Disease
- Trial name
- NCT03438383
- Testing
- Bi-PAP
- Volunteers
- 48 people
- Sponsor
- Evangelismos Hospital
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
Heart Failure
IMAGE-HF: Project IIa Canadian CArdiomyopathy Registry for Device Therapy
Delayed enhanced MRI in patients (of either ischemic or non-ischemic cause) being referred for primary prevention ICD
- Trial name
- CanCARD-MR (NCT04908306)
- Volunteers
- 502 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Fulminant Hepatic Failure
Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical…
- Trial name
- ELAD (NCT00832728)
- Testing
- Standard of Care, ELAD®
- Where
- 12 sites in United States
- Sponsor
- Vital Therapies, Inc.
Patient Transport, Respiratory Failure
HERMES: International Survey and Portable External Power Evaluation During Respiratory Support Transport
The HERMES Phase I-II study was a two-phase observational investigation designed to characterize contemporary practices and safety-related challenges associated with the transport of patients requiring advanced respiratory…
- Conditions
- Patient Transport, Respiratory Failure, Noninvasive Ventilation, High-Flow Nasal Oxygen
- Trial name
- HERMES (NCT07807189)
- Testing
- Portable External Power Supply
- Where
- 20 sites in United States, Chile and 12 more
- Volunteers
- 246 people
- Sponsor
- Medipol University
Pediatric Heart Failure
Pumps for Kids, Infants, and Neonates
PumpKIN is a multicenter, prospective, single-arm feasibility study; Evaluating the investigational Jarvik 2015 VAD in pediatric patients with heart failure.
- Trial name
- PumpKIN (NCT02954497)
- Testing
- Surgical placement of the Jarvik 2015 VAD, Surgical Placement of Jarvik 2015 VAD
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Carelon Research