Clinical trials: Clinical Performance
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
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
MultiPulse Therapy (MPT) for AF (US)
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- NCT05055921
- Testing
- Multi Pulse Therapy as delivered from the Cardialen External Stimulation System
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Cardialen, Inc.
Gastroparesis
ABCA2 GIRMS Analytical Validation Clinical Performance Study
The purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio…
- Trial name
- NCT04607304
- Testing
- ABCA2 GIRMS
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Cairn Diagnostics
Diabetes Mellitus
A Clinical Study of the C8 MediSensors Optical Glucose Monitor™
The purpose of this study is to compare glucose measurements from the C8 MediSensors non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow Springs Instrument(YSI) blood glucose analyzer.
- Trial name
- Spectrum (NCT01726114)
- Testing
- Non-invasive Optical Glucose Monitor™, YSI blood glucose analyzer
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- C8 MediSensors, Inc.
Dry Eye, Dry Eye Disease
PMCF Study to Evaluate Performance and Safety of "Ocular Drops Based Upon Carmellose" Used to Relieve Dry Eye Symptoms
Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and…
- Conditions
- Dry Eye, Dry Eye Disease, Kerato Conjunctivitis Sicca
- Trial name
- NCT05825352
- Testing
- Carmellose eye drops
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- C.O.C. Farmaceutici S.r.l.
Deafness; Sensoneural Single Sided, Conductive Hearing Loss
Clinical Performance of a New Implant System for Bone Conduction Hearing
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
- Conditions
- Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss
- Trial name
- NCT03086135
- Testing
- Osia System
- Where
- 5 sites in United States, Australia and 3 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Cochlear
Digital Nerve Injury
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial…
- Trial name
- NCT04327154
- Testing
- TISSIUM™ Nerve Coaptation Device
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- Tissium
Dry Eye Syndrome
To Demonstrate the Non-inferiority of Eyestil Protection® Compared to Vismed® in Terms of Clinical Performance
This is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups.
- Trial name
- NCT03803722
- Testing
- Eyestil Protection® unidose
- Where
- 11 sites in France, Spain
- Volunteers
- 21 people
- Sponsor
- SIFI SpA
Fertility Disorders, Infertility
Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction
This is a retrospective, observational, single-arm, multi-center study to evaluate the predictive performance of MAGENTA BLAST, an artificial intelligence (AI)-enabled software application, when used as analytical, adjunctive…
- Trial name
- NCT07464275
- Testing
- MAGENTA Blast
- Where
- Canada
- Volunteers
- 76 people
- Sponsor
- Future Fertility Inc.
Severe Knee Pain, Severe Knee Disability
Persona Revision Knee System EMEA PMCF Study
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- Trial name
- NCT07843966
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 238 people
- Sponsor
- Zimmer, GmbH
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Social Anxiety Disorder
A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to…
- Trial name
- NCT06809179
- Testing
- Fasedienol Nasal Spray - Fasedienol Nasal Spray
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- VistaGen Therapeutics, Inc.
Tendon Injuries
Adaprev in Digital Flexor Tendon Repair
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function…
- Trial name
- NCT01014494
- Testing
- Adaprev
- Where
- 9 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Renovo
Tachyarrhythmias
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT00526227
- Testing
- Secura ICD
- Where
- 13 sites in Austria, Finland and 5 more
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Breast Cancer Surgery
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.
- Trial name
- MOBIBRA (NCT06303154)
- Testing
- Mobiderm Intimate Bra group
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Thuasne
Peripheral Artery Disease, Peripheral Arterial Occlusive Disease
The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.
- Trial name
- NCT05616169
- Testing
- Easy Flype/EasyHiFlype
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- CID S.p.A.
Skin Wounds, Abrasion
A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions
Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions
- Trial name
- Dexpanthenol (NCT07642973)
- Testing
- hydrogel plaster with dexpanthenol, Standard plaster
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wooshin Labottach Co., Ltd.
Urinary Retention, Neurogenic Bladder
Connected Catheter- Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Urinary Retention, Neurogenic Bladder, Urologic Diseases
- Trial name
- NCT03843073
- Testing
- Connected Urinary Catheter
- Where
- 9 sites in United States
- Volunteers
- 9 people
- Sponsor
- Spinal Singularity
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Osteoarthritis
A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System
The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion…
- Trial name
- NCT00761410
- Testing
- P.F.C. Sigma RP-F Total Knee Replacement
- Where
- 8 sites in India, Japan and 5 more
- Volunteers
- 170 people
- Sponsor
- DePuy International