Clinical trials: medical devices, open to volunteers
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
- Type of treatment 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
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
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.
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
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.
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Diabetic Foot Ulcers (DFUs)
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Real world evidence study on the performance and safety of a nitric oxide generating dressing on the treatment of diabetic foot ulcers
- Trial name
- ONWARD (NCT07438951)
- Testing
- ConvaNiox
- Where
- United Kingdom
- Volunteers
- 102 people
- Sponsor
- ConvaTec Inc.
Epilepsy, Epilepsy (Treatment Refractory)
Diagnosing Epilepsy To EffeCT Change
The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use…
- Trial name
- DETECT (NCT07110337)
- Testing
- Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)
- Where
- 23 sites in United States
- Volunteers
- 210 people
- Sponsor
- Epiminder America, Inc.
Multiple Sclerosis
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
- Trial name
- NCT07503873
- Testing
- Ublituximab, Prefilled pen
- Where
- 45 sites in Bosnia and Herzegovina, Georgia and 4 more
- Volunteers
- 350 people
- Sponsor
- TG Therapeutics, Inc.
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