Clinical trials: Safety and Performance
Pulmonary Arterial Hypertension
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial…
- Trial name
- PILOT (NCT01092559)
- Testing
- Nitric Oxide generated by the GeNO nitrosyl delivery system
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Geno LLC
Tissue Adhesions, Surgery-Induced
Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery
Single arm study to evaluate the safety and performance of Genta-Foil resorb® for the prevention of tissue adhesions
- Trial name
- NCT04482140
- Testing
- Genta-Foil resorb®
- Where
- 3 sites in Greece, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Advanced Medical Solutions Ltd.
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paraplegia, Spinal Cord Injuries (SCI)
Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO)
ReWalk suit developed by Argo Medical Technologies is designed to enable people with lower limb disabilities to carry out routine ambulatory functions (stand, walk etc.); it can be used by people with disabilities such as spinal…
- Trial name
- NCT01251549
- Testing
- ReWalk - a motorized exoskeleton suit
- Where
- 2 sites in United States, Italy
- Volunteers
- 32 people
- Sponsor
- ReWalk Robotics, Inc.
Social Anxiety Disorder (SAD)
Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.
- Trial name
- NCT07221578
- Testing
- VQW-765
- Where
- 30 sites in United States
- Volunteers
- 500 people
- Sponsor
- Vanda Pharmaceuticals
Intervertebral Disc Degeneration
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal…
- Trial name
- TLIF (NCT05997121)
- Testing
- Transforaminal lumbar interbody fusion
- Where
- 6 sites in France, Switzerland
- Volunteers
- 187 people
- Sponsor
- SPINEVISION SAS
Knee Pain Chronic, Osteoarthritis, Knee
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty
- Conditions
- Knee Pain Chronic, Osteoarthritis, Knee, Rheumatoid Arthritis, Traumatic Arthritis
- Trial name
- NCT05787821
- Testing
- Total Knee Arthroplasty
- Where
- 16 sites in United States
- Volunteers
- 760 people
- Sponsor
- Zimmer Biomet
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
Chronic Migraine
Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
An non controlled, long term, multi center investigation
- Trial name
- NCT05843721
- Testing
- KOS (Intranasal kinetic oscillation stimulation)
- Where
- 12 sites in Germany, Israel and 2 more
- Volunteers
- 98 people
- Sponsor
- Chordate Medical
Thoracic Cancer, Head and Neck Cancer
SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors
This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and…
- Conditions
- Thoracic Cancer, Head and Neck Cancer, Pelvic Cancer, Hepatobiliary Carcinoma in Situ
- Trial name
- NCT06634706
- Testing
- RefleXion X1 Radiotherapy System [Imaging Only]
- Volunteers
- 96 people
- Sponsor
- RefleXion Medical
Removal Contraceptive Implant
Investigation to Evaluate Performance and Safety of RemovAid ™ in Removal of Contraceptive Implants
The safety and efficacy of a subdermal implant retrieval device (RemovAid) is investigated in a population of 25 women seeking removal of their palpable contraceptive implants.
- Trial name
- REVALID03 (NCT03912649)
- Testing
- RemovAid
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- RemovAid AS
Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV
Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients.
- Trial name
- NCT03085238
- Testing
- M-Trap
- Where
- 8 sites in Spain
- Volunteers
- 23 people
- Sponsor
- MTrap, Inc.
Skin Neoplasms
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.
- Trial name
- NCT02704104
- Testing
- AC5 Topical Hemostatic Device
- Where
- Ireland
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Arch Therapeutics
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03767153
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Lung Cancer
EPIONE Guided Lung Evaluation
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.
- Trial name
- EGLE (NCT05651867)
- Testing
- EPIONE device
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Quantum Surgical
Acute Ischemic Stroke
WOLF - Feasibility Neurothrombectomy Study in Acute Ischemic Stroke Patients
This study is being conducted as a feasibility clinical investigation to collect safety and technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the neurovasculature.
- Trial name
- WOLF (NCT03781622)
- Testing
- WOLF Thrombectomy Device
- Where
- 2 sites in Canada
- Sponsor
- 880 Medical, LLC
Chronic Heart Failure
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
- Trial name
- NCT04578353
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- AquaPass Medical Ltd.
AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency
Post-market Safety and Performance Outcomes of the VIVERE® Bovine Pericardial Bioprosthetic Valve
This study aims to collect post-market safety and performance data related to the procedure and follow-up of the VIVERE Bovine Pericardial Bioprosthetic Valve, when used in accordance with the product's Instructions for Use (IFU).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and Insufficiency, Aortic Valve Surgery, Mitral Valve Regurgitation
- Trial name
- VITTA (NCT06959836)
- Testing
- VIVERE Bovine Pericardial Bioprosthetic Valve
- Where
- 3 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Israel Satellite Registry
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01895712
- Where
- 6 sites in Israel
- Volunteers
- 120 people
- Sponsor
- BIOTRONIK Israel
Chronic Functional Constipation
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
- Trial name
- NCT02751411
- Testing
- micro-enema with Promelaxin, Macrogol 4000
- Where
- 4 sites in Italy
- Volunteers
- 158 people
- Sponsor
- Aboca Spa Societa' Agricola
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