Clinical trials: Medical Device
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.
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
Liver Metastases
Alpha Radiation Emitters Device (DaRT) for the Treatment of Liver Metastases
This is a single center study enrolling up to 10 patients. The primary objective is to Evaluate the feasibility and safety of the DaRT for the treatment of Liver Metastases.
- Trial name
- NCT05829291
- Testing
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Alpha Tau Medical LTD.
Dyspnea, Chest Pain
Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain
PAnDA-One is a prospective, multicenter, interventional study (10 centers, France) aimed at developing and validating a diagnostic support algorithm based on the ADx-One medical device, which non-invasively acquires thoracic…
- Trial name
- PAnDA-One (NCT07653204)
- Testing
- All patients from both groups will be imaged with airborne ultrasound device
- Where
- France
- Volunteers
- 2,500 people
- Sponsor
- Austral Diagnostics
Chest Pain, Electrocardiography
Timely Acquirement of 12-lead ECG Using Patchy-type Wireless Device Among Patient With Chest Pain
In this study, the investigators compare timely acquirement of 12-lead ECG using patchy-type wireless versus using standard 12-lead ECG system among patient with chest pain in ED.
- Trial name
- NCT04048733
- Testing
- patchy-type wireless 12-lead ECG
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Physical Activity
Measuring Outcomes With Validated Exercise
Physical activity and its intensity level is a critical determinant of health. Digital Health Technologies, such as wearable accelerometers (wrist-worn watch-like devices), can provide researchers and clinicians with objective…
- Trial name
- MOVE (NCT07270185)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Boston University
[Trial of device that is not approved or cleared by the U.S. FDA]
- Trial name
- NCT02913560
- Sponsor
- [Redacted]
Covid19, Hypoxemia
Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients
The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients.
- Trial name
- OxyJet-CPAP (NCT04681859)
- Testing
- High Flow Nasal Oxygen (HFNO) treatment, Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
- Where
- Bangladesh
- Volunteers
- 45 people
- Sponsor
- Bangladesh University of Engineering and Technology
[Trial of device that is not approved or cleared by the U.S. FDA]
- Trial name
- NCT05236361
- Sponsor
- [Redacted]
OSA
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of…
- Trial name
- SOUNDI (NCT06320795)
- Testing
- SOUNDI
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Biocubica srl
Radiodermatitis, Quality of Life
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
- Trial name
- NCT03255980
- Testing
- Xonrid® gel, Standard of Care
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Helsinn Healthcare SA
Treatment Outcome, Vascular Access
Reduction of Complications Associated With PICC Management
The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care…
- Conditions
- Treatment Outcome, Vascular Access, Vascular Access Device, Vascular Access Complication
- Trial name
- PICC managemen (NCT06944327)
- Testing
- MANAGEMENT CARE, traditional care
- Volunteers
- 460 people
- Sponsor
- Fundacion Miguel Servet