Clinical trials: Device
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA
Device Malfunction, ICD
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular…
- Conditions
- Device Malfunction, ICD, Pacemaker Lead Dysfunction
- Trial name
- ISEE (NCT04055740)
- Testing
- IVUS Imaging
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Chicago
Patient Indicated for an ICD
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled…
- Trial name
- TRUST (NCT00336284)
- Testing
- Home Monitoring, In-Office Conventional Follow-up
- Where
- 110 sites in United States, Canada
- Volunteers
- 1,450 people
- Sponsor
- Biotronik, Inc.
Stroke
Vibroacoustic Therap in Patients With Stroke
PURPOSE: to investigate the effect of vibroacoustic therapy device with laser motion guidance affect balance sensory integration in patients with stroke BACKGROUND: Following stroke, motor recovery can be dictated by the degree…
- Trial name
- NCT07206485
- Testing
- vibro-acoustic therapy, Motion Guidance Laser, selected physical therapy exercises program
- Where
- Egypt
- Volunteers
- 44 people
- Sponsor
- October 6 University
Pulmonary Hypertension
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the…
- Trial name
- COMPHI (NCT01894035)
- Testing
- Iloprost (Ventavis, BAYQ 6256)
- Where
- Portugal
- Volunteers
- 13 people
- Sponsor
- Bayer
Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders
Novel Locator-Positioner Device for Temporomandibular Joint Arthroscopy
The goal of this clinical trial is to evaluate a guide device (locator-positioner LOPO guide device) that is intended to aid the surgeon in temporomandibular joint (TMJ) arthroscopy.
- Conditions
- Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- Trial name
- TMJ-LOPO (NCT06520917)
- Testing
- Locator-Positioner (LOPO) Guide Device
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Sheba Medical Center
Femur Fracture, Periprosthetic Fracture of Hip
Dose-Response Association Between Cerclage Wire Number and Infection Risk
The purpose of this dual-center retrospective study is to investigate the relationship between the number of metallic cerclage wires used in femoral fracture surgery and the risk of developing deep infections.
- Conditions
- Femur Fracture, Periprosthetic Fracture of Hip, Periprosthetic Fracture of the Femur, Surgical Site Infection (SSI)
- Trial name
- C-INFECT (NCT07434258)
- Testing
- 1 Metallic Cerclage Wiring, 2 metalic cerclage wire, 3 metalic cerclage wire
- Volunteers
- 148 people
- Sponsor
- Istanbul University
Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease
Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Acute Pain
- Trial name
- NCT06184126
- Testing
- Virtual Reality Headset and Hand-Held Controllers, Blindfolding and Noise Cancelling
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Maryland, Baltimore
Pulmonary Embolism, Medical Device Complication
Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis
- Trial name
- NCT02917135
- Testing
- Angel® Catheter
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- BiO2 Medical
Cardio-pulmonary Bypass, AORTIC VALVE DISEASES
Clinical Validation of a Novel Handsfree Doppler Ultrasound Device, RescueDoppler, in Adult Cardiac Surgery Patients
The goal of this study is to evaluate a new device called RescueDoppler (RD), which measures continuous blood flow in the common carotid artery. The device is handsfree and operator- independent.
- Conditions
- Cardio-pulmonary Bypass, AORTIC VALVE DISEASES, Coronary Arterial Disease (CAD), Aortic Aneurysm of the Proximal Arch
- Trial name
- RD_CPB (NCT06637540)
- Testing
- RescueDoppler
- Where
- 3 sites in Norway
- Volunteers
- 42 people
- Sponsor
- St. Olavs Hospital
Wrist Fracture, Proximal Humerus Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the XtraFix® Small External…
- Trial name
- NCT05943574
- Where
- Italy
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Breast Neoplasms, Breast Cancer
Evaluation of the Feasibility of Developing Personalized Breast Cancer Radiotherapy Assistive Device With 3D Printing
Breast cancer is the most common malignancy among women worldwide. For early stage breast cancer, adjuvant radiotherapy is essential to minimize loco-regional disease recurrence.
- Conditions
- Breast Neoplasms, Breast Cancer, Left Sided Breast Cancer
- Trial name
- PERSBRA (NCT04929197)
- Testing
- PERSBRA
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- Taipei Medical University Hospital
Chemotherapy Induced Peripheral Neuropathy (CIPN)
The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy.
- Trial name
- IMPACT (NCT07142304)
- Testing
- The Lilac Device
- Where
- 18 sites in United States, Ireland
- Volunteers
- 142 people
- Sponsor
- Luminate Medical, Inc.
Asthma
The Asthma Breathing Record Study
The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform.
- Trial name
- ABRS (NCT04504838)
- Where
- United Kingdom
- Volunteers
- 124 people
- Sponsor
- TidalSense
Wound and Injuries, Surgical Wound Dehiscence
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting.
- Trial name
- NPWT (NCT02565043)
- Testing
- RENASYS TOUCH Negative Pressure Wound Therapy System
- Where
- 2 sites in South Africa
- Volunteers
- 80 people
- Sponsor
- Smith & Nephew, Inc.
Acute Respiratory Failure
Prevention of Damage Induced by Facial Mask Ventilation
In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), the main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of…
- Trial name
- 3PROSNIV (NCT01351155)
- Testing
- Skin protective dressing device
- Where
- Italy
- Volunteers
- 252 people
- Sponsor
- Ospedale San Donato
Atrial Fibrillation, Stroke
Follow-up of Kryptogenic Stroke Patients With Implantable vs. Non-invasive Devices to Detect Atrial Fibrillation.
Prospective mono-center diagnostic study determining potential discrepancies in identifying atrial fibrillation by intraindividually comparing different types of follow-up strategies: 1.
- Trial name
- TRACK-AF (NCT02641678)
- Testing
- Implantation of cardiac monitor
- Volunteers
- 106 people
- Sponsor
- University Hospital Muenster
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Postoperative Pain, Postoperative Edema
Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use
The goal of this observational registry study is to characterize postoperative recovery outcomes in adult patients receiving standard-of-care perioperative light therapy using an FDA-cleared photobiomodulation device as part of…
- Conditions
- Postoperative Pain, Postoperative Edema, Postoperative Ecchymosis, Surgical Wound Healing
- Trial name
- NCT07311889
- Testing
- Perioperative photobiomodulation light therapy
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Elixir MD Inc
Coronary Artery Stenosis
COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions.
- Trial name
- COBRA (NCT00895791)
- Testing
- AXXESS Biolimus A9-eluting bifurcation stent, culotte stenting (Xience V)
- Where
- Belgium
- Sponsor
- Universitaire Ziekenhuizen KU Leuven