Clinical trials: Performance Assessment
Aphakia, Corneal Astigmatism
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Aphakia, Corneal Astigmatism, Cataract
- Trial name
- NCT03050697
- Testing
- HARMONI® Modular Toric Intraocular Lens, Cataract extraction with intraocular lens (IOL) implantation
- Where
- New Zealand
- Volunteers
- 16 people
- Sponsor
- ClarVista Medical
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Myopia
A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.
- Trial name
- NCT01416142
- Testing
- PureVision2 HD contact lenses, Spectacles
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Bausch & Lomb Incorporated
Cardiovascular Diseases
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR
A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements
- Trial name
- NCT04098172
- Testing
- Pressure Guidewire
- Where
- 2 sites in China
- Volunteers
- 39 people
- Sponsor
- Boston Scientific Corporation
Small/Large Bowel
PillCam SB3 Capsule- Feasibility Study
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation…
- Trial name
- NCT01433042
- Testing
- capsule endoscopy
- Where
- 4 sites in Israel, Romania and 2 more
- Volunteers
- 225 people
- Sponsor
- Medtronic - MITG
Hypoxia
Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
In low oxygen environments, such as high-altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower…
- Trial name
- NCT01871142
- Testing
- Aes-103
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Colorado State University
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.
Nephrectomy, Prostatectomy
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments…
- Trial name
- NCT06119568
- Testing
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Rob Surgical Systems S.L.
Focal Dystonia
Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia
This study uses a computerized method of musical instrument digital interface (MIDI) quantification of performance before and after treatment with botulinum toxin type B (Myobloc ®, Solstice Neurosciences).
- Trial name
- NCT00208091
- Testing
- Botulinum toxin, type B
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Columbia University
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.
Evaluation of SpO2 Performance
Feasibility and Performance Evaluation of INVSENSOR00024
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
- Trial name
- NCT03831282
- Testing
- RD SET Neo SpO2
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Type 1 Diabetes, Type 2 Diabetes
Adult Accuracy Study of the Enlite 3 Glucose Sensor
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1…
- Trial name
- E3 (NCT02246582)
- Testing
- Enlite 3, Guardian Mobile App, 640G Insulin Pump
- Where
- 6 sites in United States
- Volunteers
- 118 people
- Sponsor
- Medtronic MiniMed, Inc.
Primary Open Angle Glaucoma (POAG)
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
- Trial name
- NCT02434692
- Testing
- ARGOS-IO system
- Where
- 11 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Diabetes
User Study of an Investigational Blood Glucose Monitoring System
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.
- Trial name
- NCT01447121
- Testing
- Tatsu/Tradewind Investigational BG Monitoring System
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Ascensia Diabetes Care
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
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
Pressure Ulcer
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site.
- Trial name
- NCT01438541
- Testing
- Window
- Where
- 3 sites in United Kingdom
- Volunteers
- 29 people
- Sponsor
- Molnlycke Health Care AB
Diabetes
An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy…
- Trial name
- 6-DayFU (NCT00865345)
- Testing
- MMT-7003 subcutaneous glucose sensor
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Medtronic MiniMed, Inc.
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
Major Depressive Disorder
Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression
This study was conducted to understand the use of a mobile app (titled Pathway) to help patients track depression symptoms, medications, side effects, and goals in addition to the usual care with their doctor.
- Trial name
- NCT04891224
- Testing
- Pathway Platform mobile app
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Wake Forest University Health Sciences