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)
Adiposity
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS).
- Trial name
- BARGASTRO (NCT05433688)
- Testing
- Robotic assisted gastric bypass surgery
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Breast Cancer, Breast Neoplasms
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Trial name
- DMT SV RRS1 (NCT03698942)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Diaper Rash
Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life.
- Trial name
- NCT03640897
- Testing
- Liniderm, Wipes, Water
- Where
- Poland
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Laboratoires Gilbert
Type 1 Diabetes
A Performance Evaluation of the Enlite 3 Sensor
The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor performance in arm in subjects age 14 - 75 years.
- Trial name
- NCT02649010
- Testing
- Enlite 3 Sensor
- Where
- 2 sites in United States
- Sponsor
- Medtronic MiniMed, Inc.
Peripheral Arterial Disease
BIOLUX P-III SPAIN All-Comers Registry
The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily…
- Trial name
- NCT03052296
- Testing
- Passeo-18 Lux DCB
- Where
- 5 sites in Spain
- Volunteers
- 44 people
- Sponsor
- Biotronik AG
Pulmonary Embolism (PE)
Soluble Fibrin for Diagnosing Pulmonary Embolism
The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the Soluble Fibrin Assay and the D-Dimer test.
- Trial name
- SOFIE (NCT02438462)
- Testing
- Soluble Fibrin
- Where
- France
- Volunteers
- 480 people
- Sponsor
- Diagnostica Stago R&D
Bone Metastases
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
The goal of this clinical trial was to assess the diagnostic performance and safety of Sodium Fluoride F-18 Positron Emission Tomography / Computed Tomography (18F-NaF-PET/CT) in bone metastases of malignant tumors compared with…
- Trial name
- NCT05614518
- Testing
- Sodium Fluoride F-18 Injection, Technetium[99mTc] Methylenediphosphonate Injection
- Where
- China
- Volunteers
- 280 people
- Sponsor
- HTA Co., Ltd.
Heart Failure, Ventricular Dysfunction
Safety and Performance of Electrodes Implanted in the Left Ventricle
The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure…
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases
- Trial name
- SELECT-LV (NCT01905670)
- Testing
- WiCS-LV system
- Where
- 2 sites in Czechia, Denmark
- Volunteers
- 39 people
- Sponsor
- EBR Systems, Inc.
Wound Heal, Wound; Foot
Management of Acute and Chronic Wounds With Hyaluronic Acid
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the…
- Trial name
- NCT06108999
- Testing
- Connettivina BIO cream and gauze
- Where
- 3 sites in Italy
- Volunteers
- 170 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Carcinoma, Non-Small-Cell Lung
Phase II Iressa & Carbo/Gem in NSCLC
The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.
- Trial name
- NCT00264498
- Testing
- Gefitinib, Gemcitabine, Carboplatin
- Where
- Canada
- Volunteers
- 38 people
- Sponsor
- AstraZeneca
Incision, Surgical, Surgical Incision
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14…
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent
- Trial name
- ASOLO-SCI (NCT04894604)
- Testing
- Avance® Solo NPWT System
- Volunteers
- 34 people
- Sponsor
- Molnlycke Health Care AB
Osteoarthritis, Rheumatoid Arthritis
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis
- Trial name
- NCT03626038
- Testing
- A.L.P.S. Proximal Humerus Plating System
- Where
- 7 sites in United States, Australia and 3 more
- Volunteers
- 135 people
- Sponsor
- Zimmer Biomet
Coronary Artery Disease
A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent
The clinical investigation is an international, prospective, double-blind, randomized safety and efficacy study. The purpose of this study is to evaluate the safety and performance of the NIRx(TM) Paclitaxel-Coated Stent…
- Trial name
- NCT00299026
- Testing
- NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System
- Where
- Italy
- Volunteers
- 532 people
- Sponsor
- Boston Scientific Corporation
Febrile, Healthy
The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers
Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices.
- Trial name
- NCT06353490
- Testing
- Infrared Forehead Thermometer (GE-TF03), Infrared Ear Thermometer (GE-TE06), Electronic Thermometer (MT-B321FB)
- Where
- 2 sites in Taiwan
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Geon Corporation
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Healthy Volunteers
Investigational On-body Injector Clinical Study
The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.
- Trial name
- NCT05553418
- Testing
- In-clinic wear first, Home wear first
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Becton, Dickinson and Company
Sports Physical Therapy, Dietary Habits
Investigating the Effects of Diet and Physical Activity on Esport Performance
A randomized, counterbalanced intervention study in esport players.
- Conditions
- Sports Physical Therapy, Dietary Habits, Diet, Healthy
- Trial name
- NCT05881018
- Testing
- Low glycaemic index, High glycaemic index, Physical activity
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Beneo-Institute
Cataract, Lens Opacities
Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.
- Trial name
- PHY1801 (NCT03423524)
- Testing
- Micropure 1.2.3.
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Beaver-Visitec International, Inc.
Peripheral Intravenous Catheters
RIGHT IV Pilot Study
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous…
- Trial name
- RIGHT IV (NCT01792778)
- Testing
- ViaValve Safety IV Catheter, Insyte Autoguard BC [Blood Control] Shielded IV Catheter
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Smiths Medical, ASD, Inc.
Acute Respiratory Distress Syndrome (ARDS), Pneumonia
Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
Pre-market clinical trial on 81 aldults participants to evidence safety and performance of the non-CE-marked medical device INBENTUS VERSATILE ventilator.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Pneumonia, COPD (Chronic Obstructive Pulmonary Disease), Postoperative Respiratory Distress
- Trial name
- NCT07432191
- Testing
- INBENTUS VERSATILE
- Where
- Spain
- Volunteers
- 81 people
- Sponsor
- Iconic Solutions By Murcia SL
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