Clinical trials: Medical Device
Lumbar Disc Herniation, Degenerative Spinal Stenosis
CETIS-I (CEra Traction Improves Spine-I)
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and…
- Conditions
- Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
- Trial name
- NCT05549596
- Testing
- Ceragem Master V6 Traction, Physical therapy with standard traction device
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Ceragem Clinical Inc.
Retinitis Pigmentosa
Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (RP) (QUANTUM)
Pilot, randomized, observer and participant masked, sham and fellow eye controlled, interventional clinical device trail to evaluate the safety and effectiveness of the 2C-QD device to improve visual function in adults with…
- Trial name
- NCT05841862
- Testing
- 2C-QD
- Sponsor
- 2C Tech Corp
Cardiogenic Shock, Decompensated Heart Failure
Pressure Volume Loop
The investigators are doing this study and medical record review to measure simultaneous pressure and volume of the heart called pressure volumes loops before and after ventricular assist device placement for cardiogenic shock …
- Trial name
- NCT04478188
- Testing
- Measuring Pressure Volume Loop Pre and Post Device Placement
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Cedars-Sinai Medical Center
Left Ventricular Assist Device
Blood-pressure Measuring in Patients Carrying a Left Ventricular Assist Device
To prove the novel device is able to reliably detect pulsatility in patients with CF-VADs and to analyze whether pre-programmed intrinsic pulsatility of the 3rd generation CF-VADs can also be picked up.
- Trial name
- LVAD (NCT03458988)
- Testing
- Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Pain, Anxiety
Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation.
- Trial name
- NCT01394250
- Testing
- Buzzy, Topical Lidocaine 4% Cream
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Liver Neoplasms
Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery
This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver…
- Trial name
- HEPATOFLUO (NCT01738217)
- Testing
- Fluobeam
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Centre Leon Berard
2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection
Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness: Clinical Validation
The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial…
- Conditions
- 2019 Novel Coronavirus Disease, 2019 Novel Coronavirus Infection, 2019-nCoV Disease, COVID-19 Pandemic
- Trial name
- NCT05364268
- Testing
- Diagnostic Test: Diagnostic Software as Medical Device
- Where
- United States
- Volunteers
- 514 people, healthy volunteers welcome
- Sponsor
- AudibleHealth AI, Inc.
Lung Carcinoma
Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
This clinical trial evaluates the relationship between walking and sleeping habits and surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased or less severe complications.
- Trial name
- AIRTECH (NCT04783168)
- Testing
- Best Practice, Health Promotion and Education, Medical Device Usage and Evaluation
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- M.D. Anderson Cancer Center
Spinal Muscular Atrophy, Neuromuscular Disorders
Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting
Clinical trials organization in several neuromuscular disorders (NMD) has some specific issues. Nonambulant status and difficulties with transportation are among them.
- Trial name
- NCT02235090
- Testing
- Direct current stimulation of cervical spinal cord
- Where
- Ukraine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Charitable Foundation Children with Spinal Muscular Atrophy
Congestive Heart Failure, Ischemic Cardiomyopathy
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
The purpose of the present prospective, randomized study is to investigate the clinical effectiveness of standardized left ventricular reconstruction surgery (LVR).
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease, Myocardial Diseases
- Trial name
- NCT00326690
- Testing
- Blue Egg Device
- Where
- 10 sites in United States, Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- BioVentrix
Diabetes, Diabetic Retinopathy
Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device
Diabetes affects over 37 million Americans and over 530 million people globally. Each diabetic patient needs at least one retinal exam per year starting immediately at the time of diagnosis if they have Type II diabetes (and…
- Conditions
- Diabetes, Diabetic Retinopathy, Diabetic Macular Edema, Diabetic Eye Problems
- Trial name
- NCT05368623
- Testing
- Color fundus photograph, Optical Coherence Tomography (OCT) of the retina, Mydriatic Agent
- Where
- 3 sites in United States
- Volunteers
- 1,100 people
- Sponsor
- RETINA-AI Health, Inc.
Median Sternotomy
RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy
The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk…
- Trial name
- FIXTER-2 (NCT05953259)
- Testing
- Combination of STERN FIX and wires, Wires
- Where
- 5 sites in Germany, Spain
- Volunteers
- 90 people
- Sponsor
- NEOS Surgery
Unspecified Adult Solid Tumor, Protocol Specific, Vascular Access Device Complications
Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects…
- Trial name
- NCT00607880
- Testing
- vascular access device placement
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Arrhythmias, Cardiac
RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of…
- Trial name
- NCT04556240
- Testing
- VitalConnect Platform
- Where
- United States
- Sponsor
- VitalConnect Inc.
Stroke
AI-based Upper Limb Rehabilitation Therapy With MOTORE
Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability.
- Trial name
- iMotore (NCT05238389)
- Testing
- AI-based upper limb robotic therapy
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- Fondazione Don Carlo Gnocchi ETS
Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis
Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.
- Trial name
- Vagitab (NCT06725888)
- Testing
- Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
- Where
- Romania
- Volunteers
- 30 people
- Sponsor
- S.I.I.T. Srl
Temperature Change, Body
Effect of Pressure on Skin Temperature When Using a Cryocompression Device
Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabili-tation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced…
- Trial name
- NCT05454982
- Testing
- Cryocompression
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Winchester
Atrial Fibrillation
Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study
This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.
- Trial name
- Apixaban (NCT02450682)
- Testing
- Apixaban, Warfarin
- Where
- United States
- Sponsor
- Mayo Clinic
Coronary Artery Disease, Intravascular Imaging Device
PANOVISION: Feasibility and Safety of Hybrid IVUS-OCT System
Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were all recommended for percutaneous coronary intervention (PCI) optimization in the latest guidelines, however, which imaging modality was more suitable as…
- Trial name
- NCT05596279
- Testing
- Intravascular ultrasound, Optical coherence tomography
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Harbin Medical University
[Trial of device that is not approved or cleared by the U.S. FDA]
- Trial name
- NCT07296289
- Sponsor
- [Redacted]