Clinical trials: Performance Assessment
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
Myopia
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
- Trial name
- NCT05333965
- Testing
- Lens A (lehfilcon A lens), Lens B (comfilcon A lens)
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- CooperVision, Inc.
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.
Healthy
A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Compare the fit of two pediatric face masks in children.
- Trial name
- NCT02224612
- Testing
- Medline Pediatric Face Masks, KC Childs Mask
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Teeth Straightening, Aligner Therapy
A Study to Compare Nighttime Aligners to Daytime Aligners
The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per…
- Conditions
- Teeth Straightening, Aligner Therapy, Orthodontic Aligner
- Trial name
- NCT06539676
- Testing
- Nighttime Aligners, Daytime Aligners
- Where
- 12 sites in United States
- Volunteers
- 7 people
- Sponsor
- Dentsply Sirona Implants and Consumables
Diabetes Mellitus
CareLink Connect - Technical Evaluation Study
The purpose of this study is to evaluate the performance, patient satisfaction and safety of connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose Monitoring) data from a VEO insulin pump to CareLink…
- Trial name
- NCT01989975
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 40 people
- Sponsor
- Medtronic MiniMed, Inc.
Cosmetic Appearance
Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS
The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.
- Trial name
- NCT01398787
- Testing
- Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- CIBA VISION
Heart Defects, Congenital
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle.
- Trial name
- EC-TCPC (NCT02377674)
- Testing
- Vascular Graft, Model COR-VG-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Chronic Kidney Disease
Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease
Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report participation in physical activity that falls short of recommended levels of physical activity; Children on dialysis will be less…
- Trial name
- NCT01270529
- Testing
- Increasing Physical activity
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of California, San Francisco
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Motor Performance, Physical Activity
A PATH (Promoting Activity and Trajectories of Health) for Children
Physical inactivity in children is a major public health risk factor and a health objective for the nation. This study aims to investigate the short- and long-term effects of a movement and physical activity program - the…
- Trial name
- PATH (NCT03189862)
- Testing
- Motor Skills Intervention
- Where
- United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Blood Pressure
Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization
According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure (BP) monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermittent automated measurement…
- Trial name
- NCT06609486
- Testing
- Blood pressure measurement group
- Where
- South Korea
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Hoon-Ki Park
Dental Caries
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and…
- Trial name
- NCT03788616
- Testing
- Fuji IX EXTRA, ACTIVA KIDS bioactive restorative material
- Where
- Egypt
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Marina F Fahmy, MD
Diabetes Mellitus
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
The purpose of this study is to demonstrate the performance and safety of the Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.
- Trial name
- NCT03710083
- Testing
- Guardian™ Sensor (3)
- Where
- 3 sites in China
- Volunteers
- 72 people
- Sponsor
- Medtronic MiniMed, Inc.
Glaucoma
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with…
- Trial name
- NCT03868254
- Testing
- XEN Group, Phacoemulsification
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Allergan
COVID-19, Influenza
Performance Evaluation of the Lucira COVID-19 & Flu Test
The Lucira COVID-19\& Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior…
- Trial name
- NCT06141824
- Testing
- Lucira COVID-19 & Flu Test
- Where
- 7 sites in United States
- Volunteers
- 1,361 people
- Sponsor
- Lucira Health Inc
Cognition
A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown.
- Trial name
- NCT02177942
- Testing
- Test beverage powder (High Proteins and added micronutrients), Control beverage powder (Low protein and no added micronutrients)
- Where
- India
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Localized T1-T2 Prostate Cancer
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting…
- Trial name
- NCT05407714
- Testing
- SpaceOAR Treatment
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Myopia
Evaluation of Two Daily Disposable Contact Lenses.
The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in…
- Trial name
- NCT01300065
- Testing
- Experimental- Soflens, Marketed - Soflens
- Where
- United States
- Volunteers
- 441 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Dental Caries
Post-Approval Clinical Study to Evaluate the Calcivis Caries Activity Imaging System
This is a prospective, multi-centre, post-approval clinical study to assess the safety and the performance of the Calcivis Caries Activity Imaging System in aiding the identification of active caries lesions on the occlusal…
- Trial name
- NCT02098304
- Testing
- Calcivis Caries Activity Imaging System
- Where
- 3 sites in United Kingdom
- Volunteers
- 42 people
- Sponsor
- Calcivis Ltd