Clinical trials: medical devices
Chronic Obstructive Pulmonary Disease
Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging
The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT06271408
- Testing
- Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Vibrating Mesh Nebulizer, Metered Dose Inhaler
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Polarean, Inc.
Tomography
UNITY DX Cornea Study
The purpose of this study is to validate the clinical measurement performance of an investigational biometer. Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of…
- Trial name
- NCT07768735
- Testing
- UNITY DX, ANTERION
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Alcon Research
AMI Cardiogenic Shock
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with…
- Trial name
- OASIS-AMICS (NCT06964685)
- Testing
- Impella
- Where
- 21 sites in United States
- Volunteers
- 350 people
- Sponsor
- Abiomed Inc.
Pancreatic Cancer, Pancreatic Adenocarcinoma
Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer
This is a multi-center clinical study enrolling up to 50 participants. The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity…
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer
- Trial name
- NCT06698458
- Testing
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 50 people
- Sponsor
- Alpha Tau Medical LTD.
Arthroplasty, Replacement, Hip
Trident II Tritanium Acetabular Shell Outcomes Study
The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell.
- Trial name
- NCT02999009
- Testing
- Trident II Tritanium Acetabular Shell
- Where
- 9 sites in United States
- Volunteers
- 383 people
- Sponsor
- Stryker Orthopaedics
Postoperative Pain
PK and Safety After C-Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned…
- Trial name
- NCT03955211
- Testing
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Heron Therapeutics
In-stent Thrombosis
RevCore for In Stent Thrombosis
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
- Trial name
- REVIT (NCT06394739)
- Testing
- Thrombectomy
- Where
- 17 sites in United States
- Volunteers
- 100 people
- Sponsor
- Inari Medical
Upper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)
Recombinant Collagen Freeze-Dried Fibre for Upper Facial Wrinkles
The goal of this clinical trial was to learn whether a collagen filler improved facial wrinkles. The study product was injectable recombinant collagen freeze-dried fibers.
- Trial name
- NCT07897773
- Testing
- Recombinant Collagen Freeze-Dried Fibers, Collagen Implant
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Shaanxi Giant Biotechnology Co., Ltd
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
- Trial name
- HARMONY (NCT07258069)
- Testing
- Histoacryl®
- Where
- 6 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Aesculap AG
Poor Sleep Quality, Gut Microbiome
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure…
- Conditions
- Poor Sleep Quality, Gut Microbiome, Gut Health, Inflammation
- Trial name
- NCT07848594
- Testing
- Overnight Active Temperature Regulation: Eight Sleep Pod System
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eight Sleep Inc.
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Hepatocellular Carcinoma
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome…
- Trial name
- NCT04712643
- Testing
- Atezolizumab, Becavizumab, Transarterial chemoembolization (TACE)
- Where
- 40 sites in China, Japan
- Volunteers
- 342 people
- Sponsor
- Hoffmann-La Roche
CRC Screening
Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia
The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening…
- Trial name
- NCT07894081
- Testing
- Gixam System
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Jubaan Ltd.
Healthy Aging, Alzheimer's Disease
The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation
This single-session, within-subject, sham-controlled early feasibility study evaluated the safety, tolerability, and feasibility of delivering 40 Hz audiovisual (gamma sensory) stimulation through a virtual reality (VR) headset…
- Conditions
- Healthy Aging, Alzheimer's Disease, Mild Cognitive Impairment
- Trial name
- CFS (NCT06234930)
- Testing
- Audiovisual stimulation VR system
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Clarity Health Technologies, Inc
Patellofemoral Pain Syndrome
A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome
This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.
- Trial name
- NCT06260865
- Testing
- MORA Cure, Treatment as Usual
- Where
- 10 sites in South Korea
- Volunteers
- 216 people
- Sponsor
- EverEx Inc.
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a heart condition caused by a protein called transthyretin (TTR) building up as amyloid in the heart muscle.
- Trial name
- ACO-MONITOR (NCT07557147)
- Testing
- Luscii
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Bayer
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.
- Trial name
- NCT06704672
- Testing
- Accu-Chek SmartGuide CGM Solution, Accu-Chek SmartGuide Sensor and Blinded Apps, SMBG Device
- Where
- 20 sites in Poland, Turkey (Türkiye)
- Volunteers
- 270 people
- Sponsor
- Hoffmann-La Roche
Overactive Bladder
Tensi+ European Post-Market Clinical Follow-Up
Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management.
- Trial name
- NCT07205445
- Testing
- Tensi+
- Where
- 17 sites in France, Italy and 1 more
- Volunteers
- 500 people
- Sponsor
- Stimuli Technology
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Sensorineural Hearing Loss, Tinnitus
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
- Trial name
- EXCITE (NCT07893860)
- Testing
- Cochlear implant
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Cochlear