Clinical trials: Performance Assessment
Neurogenic Bladder, Urinary Retention
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
- Neurogenic Bladder, Urinary Retention, Urologic Diseases
- Trial name
- NCT04059159
- Testing
- Connected Catheter
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Spinal Singularity
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG
Visual Acuity
Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.
- Trial name
- NCT06377488
- Testing
- JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter
- Where
- 15 sites in United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm
The study purpose is to determine the safety and efficacy of the BMFM used for the endovascular treatment of aortic aneurysm involving iliac arteries.
- Trial name
- STREAMLINER (NCT03024554)
- Testing
- Implantation of the Bifurcated Multilayer Flow Modulator
- Where
- 7 sites in Belgium, Bulgaria and 3 more
- Volunteers
- 42 people
- Sponsor
- Cardiatis
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
Diabetes
Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System
The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
- Trial name
- NCT00804596
- Testing
- Apollo Blood Glucose Monitoring System
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Ascensia Diabetes Care
Cirrhosis, Aerobic Exercises
The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis
The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with…
- Conditions
- Cirrhosis, Aerobic Exercises, Lifestyle Modification, Endothelial Function
- Trial name
- NCT06288828
- Testing
- Aerobic exercise + Nutrition consultant, Nutrition consultant
- Where
- Thailand
- Volunteers
- 50 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Parkinson's Disease (PD)
Observational Study Evaluating Robotic Spinal Mobilization in 16 Parkinson's Disease Participants. The Study Recorded Changes in Mobility, Sit-to-stand Performance, and Pain Scores After a 2-week Intervention With the BackHug Device.
The goal of this completed observational pilot study was to evaluate the immediate and short-term clinical effects of robotic spinal mobilization on motor and non-motor symptoms in community-dwelling adults with Parkinson's…
- Trial name
- NCT07384364
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Pacla Medical Limited
Ileostomy - Stoma
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
- Trial name
- NCT01957384
- Testing
- Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Hearing Loss
Ponto Implantation Using a Minimally Invasive Surgical Technique
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands).
- Trial name
- NCT04606823
- Testing
- Minimally invasive surgery, Glasgow Benefit Inventory (GBI), Additional follow-up visits after surgery
- Where
- 7 sites in Denmark, Netherlands and 2 more
- Volunteers
- 52 people
- Sponsor
- Oticon Medical
Chronic Neuropathic Pain
A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
- Trial name
- NCT02335489
- Testing
- Implantation with the commercially available Axium neurostimulator
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
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
Eczema, Psoriasis
A Clinical Investigation With Epaderm® Cream
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data is collected from approximately 120 evaluable subjects, divided into three groups of approximately 40 subjects; infants…
- Conditions
- Eczema, Psoriasis, Dry Skin; Eczema
- Trial name
- PD-539878 (NCT03738163)
- Testing
- Epaderm Cream
- Where
- 2 sites in United Kingdom
- Volunteers
- 121 people
- Sponsor
- Molnlycke Health Care AB
HIV
Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human…
- Trial name
- NCT02401555
- Testing
- Geenius HIV1/2 Supplemental Assay
- Where
- 5 sites in United States
- Volunteers
- 419 people, healthy volunteers welcome
- Sponsor
- Bio-Rad Laboratories
Prostate Cancer
Performance Evaluation of the AMS CONTINUUM™ Device
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2.
- Trial name
- NCT00894933
- Testing
- CONTINUUM™
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- American Medical Systems
Prostate Cancer
Global Performance Evaluation of the AMS CONTINUUM™ Device
1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure. 2.
- Trial name
- NCT01083199
- Testing
- CONTINUUM™
- Where
- 2 sites in Greece, Spain
- Volunteers
- 10 people
- Sponsor
- American Medical Systems
Presbyopia
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
- Trial name
- NCT05338333
- Testing
- Lehfilcon A multifocal contact lenses, Lotrafilcon B multifocal contact lenses, CLEAR CARE®
- Where
- 8 sites in United States
- Volunteers
- 101 people
- Sponsor
- Alcon Research