Clinical trials: Performance and Safety
Infrarenal Abdominal Aortic Aneurysms, Aortoiliac Aneurysms
HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
- Trial name
- NCT02087501
- Testing
- Horizon™ Abdominal Aortic Aneurysm Stent Graft System
- Where
- 7 sites in Italy, Netherlands and 2 more
- Volunteers
- 30 people
- Sponsor
- Endospan Ltd.
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
Non-Squamous Non-Small Cell Lung Cancer
An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of…
- Trial name
- ELEMENT (NCT01836133)
- Testing
- Erlotinib 150 mg
- Where
- 5 sites in Serbia
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Hepatic Disease, Renal Disease
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver…
- Trial name
- NCT05593211
- Testing
- Kronos Electrocautery Device
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Single Pass Inc
Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs
Safety and Performance of PEEK Anchors in Extremities
Safety and performance of the study devices in extremities up to 12 months post-surgery
- Conditions
- Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- NCT03782298
- Testing
- Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
- Where
- 4 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- Smith & Nephew, Inc.
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters for Females
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
- Trial name
- NCT04557787
- Testing
- SpeediCath® Standard female, New intermittent Variant 1 catheter for females, New intermittent Variant 2 catheter for females
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Cancer, Tumor, Solid
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
The purpose of this study is to assess the performance and safety of Biology-Guided Radiotherapy (BgRT) using the RefleXion Medical Radiotherapy System (RMRS) via optimizing F18-Fluorodeoxyglucose (FDG) dosing, assessing the…
- Conditions
- Cancer, Tumor, Solid, Cancer, Lung, Cancer, Bone
- Trial name
- BIOGUIDE-X (NCT04788147)
- Testing
- RMRS IDE Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- RefleXion Medical
Mitral Valve Regurgitation, Mitral Regurgitation
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the…
- Trial name
- NCT03502811
- Testing
- MitraClip NTR/XTR System
- Where
- 57 sites in United States, Germany and 6 more
- Volunteers
- 1,041 people
- Sponsor
- Abbott Medical Devices
Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA.
- Conditions
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity
- Trial name
- NCT03409666
- Testing
- Taperloc Complete Microplasty stem, Taperloc Complete Reduced Distal stem
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Stroke, Parkinson Disease
Videofluoroscopic Swallowing Study (VFSS)
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
- Conditions
- Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia
- Trial name
- PORSCHE (NCT03387267)
- Testing
- Dysphagia Detection System
- Where
- 13 sites in United States, Finland
- Volunteers
- 452 people
- Sponsor
- Société des Produits Nestlé (SPN)
Myopia, Safety Issues
The Safety and Effectiveness of Breath-O Lenses
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression.
- Trial name
- NCT03616600
- Testing
- Breath-O-Correct Lens
- Where
- Hong Kong
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Healthy
Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer
The purpose of the study is to test the performance and safety of the Bioserenity pulse oxymeter EOXY. For that, and in agreement with ISO60601-2-61 norm and FDA regulation, measures of heart rate, with a gold-standard, and SaO2…
- Trial name
- EOXY (NCT03614416)
- Testing
- EOXY device, Gold standard oximeter, SaO2 sampling
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- BioSerenity
Abdominal Injury, Thoracic Diseases
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days…
- Trial name
- NCT03515811
- Testing
- Signia™ Stapling System
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 136 people
- Sponsor
- Medtronic - MITG
Labral Tear, Glenoid, Acetabular Labrum Tear
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors…
- Conditions
- Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability
- Trial name
- NCT03985839
- Testing
- MICRORAPTOR™ REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless PEEK Suture Anchor
- Where
- 12 sites in United States
- Volunteers
- 298 people
- Sponsor
- Smith & Nephew, Inc.
Dry Eye
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes.
- Trial name
- NCT05931861
- Testing
- T2769
- Where
- 6 sites in Bulgaria
- Volunteers
- 34 people
- Sponsor
- Laboratoires Thea
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Heart Failure
A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart…
- Trial name
- NCT01831544
- Testing
- HeartWare MVAD® System
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH