Clinical trials: medical devices
Dry Eye
Performance and Safety of T2769 in DED
To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi.
- Trial name
- NCT05965778
- Testing
- T2769, Vismed® Multi
- Where
- France
- Volunteers
- 251 people
- Sponsor
- Laboratoires Thea
Healthy
Evaluating Technologies for Point-of-Care Blood Collections by Patients
A study evaluating technologies for point-of-care use in clinical trials.
- Trial name
- NCT06507566
- Testing
- Tasso+™
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Type 2 Diabetes
Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes
This is an open-label study to assess the safety and feasibility of the DyaMX device for endoscopic duodenal mucosal regeneration in individuals with type 2 diabetes inadequately controlled on glucose-lowering medications.
- Trial name
- REGENT-1 (NCT04725890)
- Testing
- The DyaMX Device
- Where
- 2 sites in Australia
- Volunteers
- 65 people
- Sponsor
- Endogenex, Inc.
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by…
- Trial name
- NCT04588428
- Testing
- INO-4700, CELLECTRA™ 2000
- Where
- 6 sites in Jordan, Kenya and 1 more
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Inovio Pharmaceuticals
Intracranial Aneurysm
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
- Trial name
- NCT04518670
- Testing
- Comaneci Embolization Assist Device
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- Rapid Medical
OsteoArthritis Knee
A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study
The goal of this randomized controlled study is to investigate the Efficacy of Using skin adhesive (Dermabond) and skin adhesive with polyester mesh (Dermabond Prineo )for Wound Closure in Total Knee Arthroplasty, The main…
- Trial name
- NCT06232018
- Testing
- Skin adhesive (Dermabond), skin adhesive + polyester mesh (Dermabond prineo)
- Where
- Thailand
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Pooriwat Lertsurawat
Cataract, Corneal Astigmatism
Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal Astigmatism
The objectives of the clinical investigation are to determine the safety and performance of the RayOne EMV Toric (Model RAO210T) following unilateral implantation and approximately 6 months (120 to 180 days) of post-operative…
- Trial name
- NCT05985304
- Testing
- RayOne EMV Toric IOL, RayOne Monofocal IOL, Cataract Surgery
- Where
- 9 sites in United States
- Volunteers
- 274 people
- Sponsor
- Rayner Intraocular Lenses Limited
Coronary Artery Bypass Graft, CABG
High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease
Background/aim: Endothelial function is closely associated with coronary artery health among individuals being treated for heart disease.
- Trial name
- NCT06127147
- Testing
- IMT
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Illinois at Chicago
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
Prosthesis User, Amputation
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on…
- Trial name
- NCT04799145
- Testing
- Investigational device, Prescribed device
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
Obstructive Sleep Apnea
Mechanisms of Upper Airway Obstruction
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep.
- Trial name
- DISE-CAD (NCT04322097)
- Testing
- Hypoglossal Nerve Stimulation
- Where
- United States
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Flank Fat
Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat
Flank region fat is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid was approved by the American FDA for treatment of flank fat.
- Trial name
- NCT07004010
- Testing
- Deoxycholic Acid Injection
- Where
- Iran
- Volunteers
- 30 people
- Sponsor
- Espad Pharmed
Pancreas Adenocarcinoma
Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line…
- Trial name
- NCT03377491
- Testing
- NovoTTF-200T, Gemcitabine, nab paclitaxel
- Where
- 199 sites in United States, Australia and 18 more
- Volunteers
- 571 people
- Sponsor
- NovoCure Ltd.
Osteoarthritis
POLARSTEM Cementless Hip Stem
Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.
- Trial name
- POLARSTEM (NCT02648152)
- Testing
- Total Hip Arthroplasty
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 218 people
- Sponsor
- Smith & Nephew, Inc.
Breast Cancer
Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy.
- Trial name
- NCT02086578
- Testing
- Breast MRI, Breast-Q© questionnaire, Multi-Beam IMRT
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Hip Fractures, Subtrochanteric Fractures
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body.
- Conditions
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures, Pertrochanteric Fracture
- Trial name
- Chimaera (NCT05197335)
- Testing
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws
- Where
- 8 sites in Italy
- Volunteers
- 206 people
- Sponsor
- Orthofix s.r.l.
Stimulant Dependence, Methamphetamine-dependence
Pilot TMS for Methamphetamine Use Disorder
This is a pilot study to test the feasibility of a recruitment strategy and study protocol to examine the effects of a dual target transcranial magnetic stimulation treatment in methamphetamine use disorder.
- Conditions
- Stimulant Dependence, Methamphetamine-dependence, Addiction, Drug
- Trial name
- NCT04449055
- Testing
- Transcranial Magnetic Stimulation--DPFC first, MPFC second, Transcranial Magnetic Stimulation--MPFC first, DPFC second
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Ryan M. Carnahan
Critical Limb Ischemia
Percutaneous Deep Vein Arterialization Post-Market Study
The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.
- Trial name
- PROMISE UK (NCT03807661)
- Testing
- Percutaneous deep vein arterialization, LimFlow System
- Where
- 6 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- LimFlow SA
Postpartum Hemorrhage
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery.
- Trial name
- NCT03064152
- Testing
- Rotational Thromboelastometry
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD
The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs)…
- Trial name
- NCT05655832
- Testing
- Vivalink wearable device
- Where
- 11 sites in Germany
- Volunteers
- 77 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany