Clinical trials: Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Condition Demonstrate Effectiveness of Virtual Simulator in Improving or Performance
- Funder type Industry (pharma, biotech, devices)
Hemorrhage, Bleeding
Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding
To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.
- Trial name
- OCCLUDE-II (NCT02033954)
- Where
- 7 sites in Austria, Belgium and 1 more
- Volunteers
- 40 people
- Sponsor
- ArtVentive Medical Group, Inc.
Obstructive Sleep Apnea
Whitsundays (Nasal) Mask Take Home Study (90 Days)
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea.
- Trial name
- NCT06036329
- Testing
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion, Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- ResMed
Presbyopia
Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
- Trial name
- NCT06469242
- Testing
- Serafilcon A multifocal contact lenses, Senofilcon A multifocal contact lenses, CLEAR CARE® Cleaning & Disinfecting Solution
- Where
- 8 sites in United States
- Volunteers
- 106 people
- Sponsor
- Alcon Research
Aortic Aneurysm, Abdominal
Suture-Tight™ First-in-Human Safety and Performance Study
Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.
- Trial name
- Suture-Tight™ (NCT05812768)
- Testing
- Suture-Tight Suture Delivery System
- Where
- Australia
- Volunteers
- 6 people
- Sponsor
- Vesteck, Inc.
Diabetes
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
- Trial name
- NCT02041286
- Testing
- Karajishi Contour Investigational BG Monitoring System
- Where
- 2 sites in United States
- Volunteers
- 136 people
- Sponsor
- Ascensia Diabetes Care
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Bisphosphonate-related Osteonecrosis of the Jaw
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for developing Bisphosphonate-related Osteonecrosis…
- Trial name
- BRONJ (NCT02218554)
- Testing
- BRONJ
- Where
- 2 sites in Israel
- Volunteers
- 150 people
- Sponsor
- Micromedic Technologies Ltd
Glaucoma Patients, Retina Patients
Performance Evaluation of Dream OCT: AP Study
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000.
- Conditions
- Glaucoma Patients, Retina Patients, Eyes With Corneal Abnormality, Normal Healthy Eyes
- Trial name
- NCT07355491
- Testing
- This is an observational study only, all patients are imaged on the investigational device
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Intalight, Inc
Restless Legs Syndrome
Simulated Driving Study in Restless Legs Syndrome
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS).
- Trial name
- XP083 (NCT01332318)
- Testing
- XP13512, Diphenhydramine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- XenoPort, Inc.
Zika Virus Infection
Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA
The purpose of this study is to evaluate the performance of the ZIKV Detect™ 2.0 IgM Capture ELISA using archived confirmed ZIKV positive and confirmed ZIKV negative human serum samples.
- Trial name
- NCT03776903
- Testing
- ZIKV Detect™ 2.0 IgM Capture ELISA
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- InBios International, Inc.
Partial Edentulism
Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
- Trial name
- NCT03283241
- Testing
- Zolidd One ExHex, One ExHex
- Where
- 3 sites in Sweden
- Volunteers
- 62 people
- Sponsor
- Addbio AB
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Advanced Heart Failure
First in Human Study of the Icoms Flowmaker
The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump…
- Trial name
- FAIR (NCT07632586)
- Testing
- Cardiac assist device implantation during surgical intervention
- Where
- 2 sites in Czechia, France
- Volunteers
- 10 people
- Sponsor
- FineHeart
Down Syndrome, Edwards Syndrome
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal…
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02787486
- Testing
- Blood sampling for Laboratory Developed Test (LDT) analysis
- Where
- 8 sites in United States
- Volunteers
- 760 people
- Sponsor
- Progenity, Inc.
Dura Mater Nick Cut or Tear, Hemostatis
Hemopatch Performance Evaluation: A Prospective Observational Registry
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
- Conditions
- Dura Mater Nick Cut or Tear, Hemostatis, Air Leakage, Body Fluid Leakage
- Trial name
- NCT03392662
- Testing
- Hemopatch
- Where
- 15 sites in Austria, Czechia and 3 more
- Volunteers
- 621 people
- Sponsor
- Baxter Healthcare Corporation
Diabetes Mellitus
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use
The aim of the study is to demonstrate the safety and performance of a novel non-invasive glucose monitoring device, to collect data and reference measurements for establishment of calibration models and to evaluate the…
- Trial name
- NCT04033042
- Testing
- Prototype 0.5
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- RSP Systems A/S
Healthy
Adhesion of Lidocaine Topical System 1.8%
The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.
- Trial name
- NCT04312750
- Testing
- Lidocaine topical system 1.8%
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Scilex Pharmaceuticals, Inc.
Sleep Apnea
Validation of a Contactless Vital Signs Measurement Sensor
The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography.
- Trial name
- NCT04676191
- Testing
- Sleepiz One+, Polysomnography
- Where
- Switzerland
- Volunteers
- 64 people
- Sponsor
- Sleepiz AG
ABO Blood Type, RhD Blood Type
Performance Study of the INSTI® and TruPlex Rapid Blood Typing Platforms
CLS-019A is a prospective, multi-site, parallel clinical performance study. Each enrolled subject is tested on both investigational devices in parallel within a single study visit, yielding paired INSTI® and TruPlex results from…
- Trial name
- NCT07770360
- Testing
- INSTI® Rapid Blood Type Test, TruPlex Rapid Blood Type Test
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
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
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