Clinical trials: Performance
Astigmatism
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
- Trial name
- NCT04831515
- Testing
- Lens A, Lens B
- Where
- 4 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- CooperVision, Inc.
Peripheral Artery Disease
Cocoa to Improve Walking Performance in Peripheral Artery Disease
The COCOA-PAD trial will determine whether epicatechin-rich cocoa daily for six months improves walking performance in individuals with peripheral artery disease compared to placebo.
- Trial name
- COCOA-PAD (NCT02876887)
- Testing
- Cocoa
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Northwestern University
Catheter Site Pain, Catheter Site Discomfort
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22…
- Trial name
- NCT04633291
- Testing
- Novel swelling media, Comparator swelling media
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Cataract
Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.
- Trial name
- NCT04224155
- Testing
- enVista MX60EFH trifocal intraocular lenses (IOLs), enVista MX60E monofocal intraocular lenses (IOLs)
- Where
- 9 sites in Canada
- Volunteers
- 165 people
- Sponsor
- Bausch & Lomb Incorporated
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.
Body Temperature Changes
Cooling Vest May Reduce Heat Stress During Surgery
The investigators will propose a randomized cross-over trial using a uniform and strongly balanced 4-period design in which will include four operations for each surgeon.
- Trial name
- NCT04511208
- Testing
- Cooling Vest, Without cooling vest
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Healthy
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions.
- Trial name
- NCT03134326
- Testing
- R1-25 and R2-25 Pulse Oximeter Sensor
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
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
Myopia
Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.
- Trial name
- NCT00933166
- Testing
- Lotrafilcon A contact lens
- Volunteers
- 169 people
- Sponsor
- CIBA VISION
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
Glioblastoma Multiforme
Radiosurgery for Glioblastoma Multiforme
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor…
- Trial name
- NCT00456612
- Testing
- CyberKnife
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Beth Israel Deaconess Medical Center
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.
Neuroendocrine Neoplasms
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
The purpose of this study was to evaluate the diagnostic performance of [68Ga]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in…
- Trial name
- NCT06240741
- Testing
- [68Ga]Ga-DOTA-TATE, 68Ge/68Ga Generator
- Where
- 8 sites in Japan
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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.
Corneal Topography
Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer
The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.
- Trial name
- NCT01861925
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Haag-Streit AG