Clinical trials: Performance and Safety
Hallux Limitus of Left Great Toe, Rheumatoid Arthritis
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants.
- Conditions
- Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis
- Trial name
- NCT02350881
- Testing
- Primus FGTI (Flexible Great toe Implant)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Stryker Trauma and Extremities
Pregnancy
Safety and Performance of a Fetal Monitoring System
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
- Trial name
- M•CARE SE (NCT05294211)
- Testing
- M•care™ System, Cardiotocography (CTG)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Marani Health
Injections, Intradermal
Performance and Safety Evaluation of an Intradermal Delivery Device
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.
- Trial name
- NCT01359111
- Testing
- PATH ID Adapter
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- PATH
Glaucoma
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg…
- Trial name
- NCT00772330
- Testing
- Glaucoma Drainage Device
- Where
- Dominican Republic
- Volunteers
- 23 people
- Sponsor
- InnFocus Inc.
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Hearing Loss
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751.
- Trial name
- NCT04754477
- Testing
- Active Osseointegrated Steady-State Implant System (OSI)
- Where
- 3 sites in Australia, Hong Kong
- Volunteers
- 20 people
- Sponsor
- Cochlear
Femoral Arteriotomy Closure
MANTA Registry for Vascular Large-bore Closure
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for…
- Trial name
- MARVEL (NCT03330002)
- Testing
- CE-marked MANTA vascular closure device (VCD)
- Where
- 9 sites in Canada, Denmark and 3 more
- Volunteers
- 500 people
- Sponsor
- Essential Medical, Inc.
Small Bowel Disease
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).
- Trial name
- SAMISEN (NCT03955081)
- Testing
- Deep enteroscopy
- Where
- 10 sites in Belgium, Denmark and 4 more
- Volunteers
- 302 people
- Sponsor
- Olympus Europe SE & Co. KG
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Coronary Arteriosclerosis
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
- Trial name
- NCT00968019
- Testing
- Presillion stent
- Where
- 13 sites in Portugal, Spain
- Volunteers
- 318 people
- Sponsor
- Johnson and Johnson, S.A.
Atrial Fibrillation, Atrial Flutter
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Surgical Scar, Breast Augmentation
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift.
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Trial name
- NCT03467724
- Testing
- Fractional Radiofrequency (FRF)
- Where
- Spain
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Pulmonary Arterial Hypertension
Nitric Oxide, GeNO Nitrosyl Delivery System
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC.
- Trial name
- NCT01165047
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Roux En Y Gastric Bypass
Safety and Efficacy Study of Duet TRS
The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
- Trial name
- NCT00950872
- Testing
- Duet TRS
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Septoplasty
Safety and Performance of ENTACT Septal Staple System for Septoplasty
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects.
- Trial name
- NCT04392583
- Testing
- ENTACT Septal Staple system
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Catheterization Via a Femoral Sheath ≤ 6Fr
CaveoVasc System - a New Femoral Vascular Access and Closure Device
The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.
- Trial name
- NCT02694549
- Testing
- CaveoVasc
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- CaveoMed GmbH
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
Benign Prostatic Hyperplasia (BPH)
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
- Trial name
- NCT04823221
- Testing
- Rezūm System
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Boston Scientific Corporation
Healthy Subjects
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part I
The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.
- Trial name
- NCT05111847
- Testing
- Short-term Baseplates first then long-term Baseplates, Long-term Baseplates first then short-term Baseplates
- Where
- Denmark
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- UNEEG Medical A/S
Attention Deficit/Hyperactivity Disorder (ADHD)
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD.
- Trial name
- NCT00418184
- Testing
- Phosphatidylserine-Omega3, Colored cellulose tainted with fishy odor
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Enzymotec