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)
Cataract
Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.
- Trial name
- NCT05025345
- Testing
- Tecnis Eyhance, Tecnis 1 piece IOL
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Peripheral Arterial Disease
POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling
The POWER-PAD-1 Study is a first-in-human evaluation of the safety and performance of the Pulse Peripheral Intravascular Lithotripsy (IVL) Balloon Catheter to enroll up to twenty (20) subjects.
- Trial name
- POWER-PAD-1 (NCT05192473)
- Testing
- Pulse Intravascular Lithotripsy System
- Where
- 3 sites in Australia, Dominican Republic and 1 more
- Volunteers
- 9 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Lipolysis
RF and PEMF Following Liposuction
The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation.
- Trial name
- NCT03588702
- Testing
- RF and PEMF treatment
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Benign Prostatic Hyperplasia
The Zenflow Spring System Safety and Performance Study (ZEST CAN)
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
- Trial name
- NCT04309695
- Testing
- Zenflow Spring System
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Zenflow, Inc.
Endotracheal Tube, Mechanical Ventilation
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with…
- Trial name
- NCT01547507
- Testing
- AirWay Medix Closed Suction System
- Where
- Israel
- Volunteers
- 26 people
- Sponsor
- Biovo Technologies Ltd
SARS-CoV-2 Acute Respiratory Disease
Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19)
A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19…
- Trial name
- NCT06360757
- Testing
- NeuMoDx SARS-CoV-2 Assay
- Where
- United Kingdom
- Volunteers
- 503 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Stroke, Parkinson Disease
Videofluoroscopic Swallowing Study (VFSS)
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
- Conditions
- Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia
- Trial name
- PORSCHE (NCT03387267)
- Testing
- Dysphagia Detection System
- Where
- 13 sites in United States, Finland
- Volunteers
- 452 people
- Sponsor
- Société des Produits Nestlé (SPN)
Peripheral Artery Disease, Peripheral Vascular Disease
Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe
BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE.
- Trial name
- BIOFLEX-I EU (NCT01661231)
- Testing
- Astron/Pulsar-18 stent
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 456 people
- Sponsor
- Biotronik AG
Urine Output, ICU Patients
Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU
The goal of this observational pilot study is to learn about the ability of the PureWick® Flex Female External Catheter and the PureWIck® Male External Catheter to capture urine output in adult ICU patients compared to indwelling…
- Trial name
- NCT07744945
- Testing
- Indwelling Urinary Catheter, External Urinary Catheter
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- C. R. Bard
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.
Fertility Disorders
Performance of CHLOE Algorithm on the Prediction of Blastocyst Formation
This is an observational, prospective, single-arm, multi-center, clinical study to evaluate the performance of CHLOE, an Artificial Intelligence (AI)-based software application, as adjunct information to support identifying…
- Trial name
- CHLOE (NCT05455281)
- Testing
- CHLOE
- Where
- 3 sites in United States, Israel
- Volunteers
- 55 people
- Sponsor
- Fairtility
Myopia
Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)
To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision…
- Trial name
- FIN-3102 (NCT07668102)
- Testing
- HAL spectacle lens, Single Vision spectacle lens
- Where
- 7 sites in United States
- Volunteers
- 88 people
- Sponsor
- Essilor International
Coronary Artery Disease
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.
- Trial name
- NCT01426139
- Testing
- Percutaneous Coronary Intervention Biotronik Orsiro DES
- Where
- 4 sites in India
- Volunteers
- 120 people
- Sponsor
- Biotronik AG
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
Hyperglycemia
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.
- Trial name
- MAHI (NCT01763567)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Medtronic MiniMed, Inc.
Caries Pit and Fissure Limited to Enamel
Clinical Performance of Two Fissure Sealants
Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
- Trial name
- NCT03470129
- Testing
- fissure sealing
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Ivoclar Vivadent AG
Trauma
Trauma Equivalency Study of the CORA® and TEG® 5000 Systems
This study is being performed to obtain data about the CORA System when used in a trauma clinical setting. The CORA analyzer is a new device that is currently being tested in trauma clinical applications and is not yet cleared…
- Trial name
- NCT02408029
- Testing
- Observational study - no intervention
- Where
- 3 sites in United States
- Volunteers
- 325 people
- Sponsor
- Coramed Technologies LLC
Pain; Bone Neoplasms; Neoplasm Metastasis
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease
This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain.
- Trial name
- NCT02561039
- Testing
- Ibandronate
- Where
- 9 sites in Bulgaria
- Volunteers
- 97 people
- Sponsor
- Hoffmann-La Roche