Clinical trials: Safety and Performance
Cardiac Surgery, Heart Surgery
Novel Venous Cannula Trial
This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous…
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Minimally Invasive Surgical Procedures
- Trial name
- NCT07087639
- Testing
- Self-expanding Venous Cannula
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Eurosets S.r.l.
Polyp of Colon, Endoscopic Mucosal Resection
EndoRotor® Endoscopic Mucosal Resection System for the Colon
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic…
- Conditions
- Polyp of Colon, Endoscopic Mucosal Resection, Recurrent Colon Adenoma
- Trial name
- NCT04203667
- Testing
- EndoRotor Resection
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 66 people
- Sponsor
- Interscope, Inc.
Mandible Fracture, Mandibular Reconstruction
Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting…
- Trial name
- SMRP (NCT07221916)
- Testing
- Mandibular Reconstruction
- Where
- 2 sites in United States, Germany
- Volunteers
- 70 people
- Sponsor
- Stryker Craniomaxillofacial
Organ Transplant, Ischemic Reperfusion Injury
PERTRIAL - Perla® Preservation Solution
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
- Trial name
- NCT05194306
- Testing
- Perla® Cold Preservation solution
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Advanced Life Solutions
Rheumatoid Arthritis
The SetPoint System Safety & Performance Post-Approval Study
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System [implanted, vagus-mediated, neuroimmune modulator] for the…
- Trial name
- ACTIVATE (NCT07489326)
- Testing
- SetPoint System
- Volunteers
- 150 people
- Sponsor
- SetPoint Medical Corporation
Inguinal Hernia
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
- Trial name
- NCT01193985
- Testing
- TIGR Matrix Surgical Mesh
- Where
- 2 sites in Sweden
- Volunteers
- 40 people
- Sponsor
- Novus Scientific
Prostate Cancer
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand…
- Trial name
- NCT04186819
- Testing
- rhPSMA-7.3 (18F) Injection, Positron Emission Tomography scan
- Where
- 34 sites in United States, Finland and 2 more
- Volunteers
- 356 people
- Sponsor
- Blue Earth Diagnostics
Chronic Low Back Pain (CLBP)
Clinical Investigation to Assess the Clinical Effect of the LumbaCure® Intervention on Patients Suffering From Chronic Low Back Pain
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020.
- Trial name
- LumbaCure2302 (NCT06662032)
- Testing
- LumbaCure®, Rehab program
- Where
- 2 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- Odix
Healthy
Safety and Performance Evaluation of the Rapid Ring Device
The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.
- Trial name
- NCT01152983
- Testing
- Rapid Ring
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- RapiDx Ltd.
Hip Osteoarthritis, Rheumatoid Arthritis
G7 Dual Mobility With Vivacit-E or Longevity PMCF
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of…
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis
- Trial name
- NCT05548972
- Testing
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 358 people
- Sponsor
- Zimmer Biomet
Epilepsy
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
- Trial name
- NCT01178437
- Testing
- T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- cerbomed GmbH
Stroke, Healthy
Study to Evaluate Performance, Usability, Safety of Microwave Technology When Collecting Data From Patients With Stroke
This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers.
- Trial name
- NCT02266459
- Testing
- Microwave technology (Medfield Diagnostics)
- Where
- 3 sites in Sweden
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Medfield Diagnostics
Heart Failure
V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance CHF
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
- Trial name
- NCT05712824
- Testing
- V-LAP™ SYSTEM
- Where
- 3 sites in Georgia
- Volunteers
- 10 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Glaucoma, Open Angle Glaucoma
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate both the safety and feasibility of the surgical implantation of the ARGOS-SC implant during non-penetrating glaucoma surgery and the safety and usability of the ARGOS-SC implant and system…
- Trial name
- ARGOS-SC01 (NCT03756662)
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Implandata Ophthalmic Products GmbH
Acute Rhinitis, Nasal Obstruction
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories.
- Conditions
- Acute Rhinitis, Nasal Obstruction, Rhinosinusitis, Rhinopharyngitis
- Trial name
- DEVALPO (NCT05494346)
- Testing
- Measurement of peak nasal flow.
- Where
- 5 sites in France
- Volunteers
- 101 people
- Sponsor
- Laboratoires Gilbert
Venous System, Venous Access
A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance.
- Conditions
- Venous System, Venous Access, Chemotherapy, Antibiotics
- Trial name
- NCT05519787
- Testing
- Central Veinous access devices' insertion
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Perouse Medical
Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee
Safety and Performance of the Journey™ II UNI Unicompartmental Knee System
This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment…
- Trial name
- JII-Uni (NCT03768128)
- Testing
- Journey™ II UNI Unicompartmental Knee System
- Where
- 6 sites in United States, Italy and 1 more
- Volunteers
- 154 people
- Sponsor
- Smith & Nephew, Inc.
Coronary Artery Disease
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 people
- Sponsor
- Abbott Medical Devices
Non-valvular Atrial Fibrillation
The CONFORMAL Early Feasibility Study
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
- Trial name
- NCT03616028
- Testing
- left atrial appendage closure
- Where
- 11 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Conformal Medical, Inc
Coronary Artery Stenosis
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family
The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Trial name
- NCT05232565
- Testing
- Percutaneous Transluminal Coronary Angioplasty
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Arthesys
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