Clinical trials: medical devices
Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions
The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.
- Conditions
- Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Bifurcation of Coronary Artery, Multi Vessel Coronary Artery Disease
- Trial name
- DYNAMITE (NCT05464147)
- Testing
- DynamX Drug-Eluting Coronary Bioadaptor System
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Elixir Medical Corporation
Diabetic Foot Ulcer, Chronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers.
- Trial name
- NCT07444593
- Testing
- Biodynamik XT3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Biodynamik, Inc
Type 2 Diabetes, Liver Disease
Digital Behavioral Therapy to Reduce Diabetes and Liver Disease Risk
This clinical trial aims to find out if a digital behavioral program, delivered through the SIPPA digital therapeutics app, can help improve blood sugar control and lower the risk of liver fibrosis in adults with type 2 diabetes…
- Trial name
- SIPPA-QH_HHC-2 (NCT07032311)
- Testing
- Behavioral Treatment
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- SIPPA Solutions INC
Carpal Tunnel Syndrome, CTS
Registry of the Patient Experience for Carpal Tunnel Release
Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).
- Trial name
- MISSION (NCT06071468)
- Testing
- UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US), Endocscopic CTR, Open CTR
- Where
- 33 sites in United States
- Volunteers
- 1,424 people
- Sponsor
- Sonex Health, Inc.
Carotid Artery Diseases, Aortic Diseases
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement…
- Conditions
- Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases
- Trial name
- NCT07322913
- Testing
- Intergard Standard - Collagen Coated Vascular Grafts and Patches, Hemashield - Collagen Coated Vascular Grafts and Patches, Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches
- Where
- 5 sites in United States, Belgium and 2 more
- Volunteers
- 1,200 people
- Sponsor
- Intervascular
Heart Failure
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with…
- Trial name
- HFrEF (NCT02880618)
- Testing
- Barostim Neo™ System
- Where
- 30 sites in Germany, Italy
- Volunteers
- 500 people
- Sponsor
- CVRx, Inc.
Cholecystectomy, Robotic
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults.
- Trial name
- NCT07096856
- Testing
- Robotic assisted cholecystectomy
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- CMR Surgical Ltd
Overactive Bladder (OAB)
Tensi+ for Treating Overactive Bladder
The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency…
- Trial name
- NCT07300904
- Testing
- Tensi+
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Stimuli Technology
Obesity, Type 2 Diabetes
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI…
- Trial name
- NCT07085741
- Testing
- MAGNET System, DI Biofragmentable
- Where
- Mexico
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
Uncontrolled Hypertension
BAROSTIM NEO Hypertension Pivotal Trial
The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
- Trial name
- NCT01679132
- Testing
- BAROSTIM NEO System and Medical Management
- Where
- 11 sites in United States
- Volunteers
- 10 people
- Sponsor
- CVRx, Inc.
Tendinopathy, Insertional Achilles Tendinopathy
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.
Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis.
- Conditions
- Tendinopathy, Insertional Achilles Tendinopathy, Achilles Tendinopathy, Peritendinitis
- Trial name
- AKITENMED (NCT05464498)
- Testing
- MD-Tissue Collagen Medical Device, eccentric strengthening protocol
- Where
- Italy
- Volunteers
- 72 people
- Sponsor
- Guna S.p.a
Root Canal Treatment
Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone Protocols
A prospective, parallel-group, randomised, post-market clinical follow-up investigation evaluating the performance and safety of the modified formula of the AH Plus Jet® Endodontic Sealer (also referred to as ES) and the…
- Trial name
- NCT07642284
- Testing
- AH Plus Jet® Endodontic Sealer, AH Plus Jet® Root Canal Sealing Material
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Peripheral Arterial Disease
Advanta VXT and Flixene PMCF Registry
The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries.
- Trial name
- NCT07161583
- Testing
- Advanta VXT Vascular Graft, Flixene Vascular Graft
- Where
- 2 sites in United States, France
- Volunteers
- 1,000 people
- Sponsor
- Atrium Medical Corporation
Liver Neoplasms, Primary Liver Cancer
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors.
- Conditions
- Liver Neoplasms, Primary Liver Cancer, Secondary Liver Cancer, Tumor Liver
- Trial name
- NCT06486454
- Testing
- HistoSonics Edison System
- Where
- 33 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- HistoSonics, Inc.
Hypertension
BAROSTIM THERAPY™ In Resistant Hypertension
The purpose of this registry (NCT02880631) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant…
- Trial name
- NCT02880631
- Testing
- BAROSTIM NEO™ System
- Where
- 26 sites in Germany, Netherlands
- Volunteers
- 500 people
- Sponsor
- CVRx, Inc.
Spinal Cord Injury
Health and Financial Impact on the Use of a Personal Exoskeleton in the Home and Community: a Case Study
The goal of this clinical trial is to examine the long-term use of a personal overground robotic exoskeleton in subjects with spinal cord injury. The main aims of this study include: 1.
- Trial name
- NCT07030322
- Testing
- Overground Robotic Exoskeleton
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Ekso Bionics
Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1
Evidence For Fusion In Spine With Orthoss®
This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
- Conditions
- Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis, Lumbar Disc Degeneration
- Trial name
- EFFISO (NCT03853356)
- Testing
- Orthoss
- Where
- 3 sites in Germany
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Geistlich Pharma AG
Heart Failure
BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction
The purpose of this registry (NCT02876042) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO system in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant…
- Trial name
- HFpEF (NCT02876042)
- Testing
- BAROSTIM NEO™ System
- Where
- 13 sites in Germany
- Volunteers
- 11 people
- Sponsor
- CVRx, Inc.
Mitral Regurgitation, Mitral Stenosis
Cephea South America Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT07244939
- Testing
- Cephea Mitral Valve System
- Where
- 3 sites in Brazil, Chile
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Non Valvular Atrial Fibrillation
Append Prague Study
This study is intended to evaluate the safety and feasibility of the Append System for left atrial appendage (LAA) elimination using a transcatheter procedure that invaginates and ligates the LAA tissue.
- Trial name
- NCT07816029
- Testing
- Append System
- Where
- Czechia
- Volunteers
- 75 people
- Sponsor
- Append Medical Ltd.