Clinical trials: medical devices
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
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
Cardiovascular Diseases, Arrhythmias, Cardiac
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac…
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
- Trial name
- ICE-ACCESS (NCT07788040)
- Testing
- Intracardiac Echocardiography Catheter
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
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
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
Diabetes (DM)
RIGHTEST iFree 2 CGM System for Glycemic Control in Adults With Diabetes Mellitus
The goal of this clinical trial is to find out whether using a real-time continuous glucose monitoring (CGM) system can improve daily blood sugar control compared with usual self-monitoring of blood glucose (SMBG; finger-stick…
- Trial name
- NCT07889375
- Testing
- Continuous Glucose Monitoring (CGM), Self-monitoring of blood glucose (SMBG)
- Where
- Taiwan
- Volunteers
- 324 people
- Sponsor
- Bionime Corporation
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
Pain
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.
- Trial name
- NOVABLOC-TKA (NCT07191067)
- Testing
- Percutaneous radiofrequency electrical nerve stimulation, Non-therapeutic stimulation
- Where
- 5 sites in United States
- Volunteers
- 123 people
- Sponsor
- Synaptrix, Inc.
Aortic Regurgitation, Aortic Valve Insufficiency
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ARTIST (NCT06608823)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System, SAVR
- Where
- 38 sites in United States
- Volunteers
- 1,016 people
- Sponsor
- JenaValve Technology, Inc.
Colorectal Cancer, Polyp of Colon
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.
- Conditions
- Colorectal Cancer, Polyp of Colon, Adenoma Colon
- Trial name
- EAGLE (NCT05730192)
- Testing
- Colonoscopy with CADDIE, Standard Colonoscopy
- Where
- 8 sites in Germany, Italy and 2 more
- Volunteers
- 985 people
- Sponsor
- Odin Medical
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.
Acute Pulmonary Embolism
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.
- Trial name
- ANTEATER (NCT06819865)
- Testing
- EkoSonicTM Endovascular System
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Boston Scientific Corporation
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT07538609
- Testing
- GORE® VIABAHN® FORTEGRA Venous Stent
- Where
- 4 sites in United States
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
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
Atrial Fibrillation
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).
- Trial name
- NCT07651852
- Testing
- Globe Pulsed Field System
- Where
- 2 sites in United States
- Volunteers
- 500 people
- Sponsor
- Kardium Inc.
Skin Physiology After Fractional CO₂ Laser Treatment, Skin Physiology After Thermage Treatment
Pre- and Post-procedure Skin Knowledge Study
The goal of this exploratory clinical trial is to characterize and compare skin clinical signs, skin physiology and subjective well-being before and after CO₂ fractional laser or Thermage treatment.
- Trial name
- NCT07895303
- Testing
- CO₂ fractional laser skin treatment, Thermage skin tightening treatment, Neutral broad-spectrum sunscreen
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ChinaNorm
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
Lower Limb Ischaemia
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
A prospective, single arm pilot efficacy study designed to evaluate the physiological and symptomatic effects of normobaric Nasal High Flow (NHF) oxygen therapy in patients with lower limb ischaemia experiencing rest pain and/or…
- Trial name
- NCT07891208
- Testing
- Nasal high flow oxygen
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
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.
Pregnancy
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing.
- Trial name
- NCT06516211
- Testing
- Clara Pregnancy Test, Professional Marketed Pregnancy Test
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Conceptra Biosciences, LLC
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