Clinical trials: Performance Assessment
Obstructive Sleep Apnea
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask.
- Trial name
- NCT02121912
- Testing
- FPH Pilairo Q CPAP mask, Any other market released nasal or nasal-pillow CPAP mask
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Myopia
A Study to Evaluate a Modified Contact Lens
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently…
- Trial name
- NCT01391364
- Testing
- SofLens in investigational solution, SofLens in currently marketed solution
- Where
- United States
- Volunteers
- 438 people
- Sponsor
- Bausch & Lomb Incorporated
Dry Eye Syndromes
Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.
- Trial name
- IMPACT (NCT02121847)
- Testing
- cyclosporine 0.05% ophthalmic emulsion, carboxymethylcellulose-based lubricant eye drops
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Allergan
Lung Cancer
Auris Robotic Endoscopy System for Bronchoscopy
In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.
- Trial name
- NCT03497026
- Testing
- Robotic Bronchoscopy Platform
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Auris Health, Inc.
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Sleep, Mood
Investigational Test of a New Sleep Supplement
This study seeks to observe the effects of a proprietary spearmint extract and green tea blend on sleep quality and duration. The study observes the effect of the supplement regarding sleep quality, and mental health.
- Conditions
- Sleep, Mood, Cognitive Performance
- Trial name
- InTeNSS (NCT03567343)
- Testing
- Proprietary Spearmint Extract Blend, Control
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Arizona
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Inflammatory Response
Effects of Metformin in a Non-Diabetic Patient Population
Metformin has a well-established safety profile and it has become clear that metformin has additional salutary effects, including anti-inflammatory, anti-aging, and anti-thrombotic properties.
- Trial name
- NCT03772964
- Testing
- MetFORMIN Hydrochloride ER
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Brian Zuckerbraun
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
Astigmatism
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
- Trial name
- NCT05933772
- Testing
- Lens A (comfilcon A toric lens), Lens B (lehfilcon A toric lens)
- Where
- 5 sites in United States, Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CooperVision International Limited (CVIL)
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S
Benign Brain Tumor, Malignant Brain Tumor
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing…
- Trial name
- cCeLLExvivo (NCT06098248)
- Testing
- cCeLL - Ex vivo
- Where
- 4 sites in Canada, South Korea
- Volunteers
- 285 people
- Sponsor
- VPIX Medical
Acne Scars
Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring.
- Trial name
- NCT03767153
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Insulin Requiring Diabetes
CEP249 Pediatric Accuracy Study
The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance in pediatric patients with insulin requiring diabetes at the beginning, middle and end of sensor wear.
- Trial name
- NCT01991470
- Testing
- Enlite sensors
- Where
- 11 sites in United States
- Volunteers
- 186 people
- Sponsor
- Medtronic MiniMed, Inc.
Lung Cancer, Cancer
Bintrafusp Alfa Program Rollover Study
This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706…
- Trial name
- NCT05061823
- Testing
- Bintrafusp alfa
- Where
- 21 sites in United States, Belgium and 10 more
- Volunteers
- 22 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Insomnia
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid.
- Trial name
- NCT01106859
- Testing
- zopiclone, zolpidem tartrate sublingual tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Transcept Pharmaceuticals
Acute Concussion Syndrome
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome.
- Trial name
- RECOVERY (NCT05647304)
- Testing
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Where
- France
- Volunteers
- 50 people
- Sponsor
- REGEnLIFE SAS
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
Dental Caries
Safety and Performance Evaluation of the Calcivis System
This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System.
- Trial name
- NCT02780856
- Testing
- Imaging with the Calcivis System
- Where
- 4 sites in United Kingdom
- Volunteers
- 110 people
- Sponsor
- Calcivis Ltd
Ocular Discomfort
A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
The objective of this study is to evaluate the clinical performance of Bausch \& Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV…
- Trial name
- NCT01024751
- Testing
- Bausch & Lomb Multi-Purpose Solution, Ciba's Multi-Purpose Solution
- Where
- United States
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated