Clinical trials: Medical Device
Medical Device
Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.
- Trial name
- SMARTANGEL (NCT05380310)
- Testing
- Active "SMART ANGEL" solution, Inactive "SMART ANGEL" solution
- Where
- France
- Volunteers
- 2,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Medical Device
Technical Capabilities of the "SMART ANGEL Intra-hospital" System 's Connected Medical Device (CMD)
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.
- Trial name
- SMART-METRO (NCT04668807)
- Testing
- Connected Medical Device, Traditional transmission system
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Premature Ejaculation, Masturbation
Efficacy of App and Electronic Device in the Treatment of Premature Ejaculation
Randomized control trial to determine if we can produce increases in the IELT using a new masturbator electronic in subjects with premature ejaculation in combination with a exercise app, producing improvements in the quality and…
- Conditions
- Premature Ejaculation, Masturbation, Medical Device
- Trial name
- NCT04012437
- Testing
- Sphincter Control Training (SCT)
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Instituto Sexológico Murciano
Diabete Mellitus, Medical Device
Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes
The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3
- Trial name
- NCT03781232
- Testing
- Prototype 0.3
- Where
- 2 sites in Germany
- Volunteers
- 47 people
- Sponsor
- RSP Systems A/S
Safety Issues, Medical Device
Innovative Device for Intravenous Administration
The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as…
- Trial name
- SeringaDUO (NCT04046770)
- Testing
- Drug administration and Flushing procedure using Double-Chamber Syringe, Drug administration and Flushing procedure using Classic Syringe
- Volunteers
- 146 people
- Sponsor
- Escola Superior de Enfermagem de Coimbra
Medical Device
Development of a Segmental Bioelectrical Impedance Spectroscopy Device for Body Composition Measurement
A device for measuring body composition with a small electric current, at 200 μA, (bioelectrical impedance analysis, or BIA) was designed.
- Trial name
- NCT04006899
- Testing
- Bioelectrical Impedance Monitor
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Jun Choi
Medical Device, User-Computer Interface
VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU
The VitalPAD is a unified, portable and intelligent device that integrates information from multiple patient monitors, mechanical ventilators, infusion pumps and clinical information systems on a mobile platform.
- Conditions
- Medical Device, User-Computer Interface, Critical Care, Physiologic Monitoring
- Trial name
- NCT02970903
- Testing
- VitalPAD, Traditional tools
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of British Columbia
Medical Device
"Vibwife One" a New Medical Device to Support Delivering Women in Their Mobilization
"Vibwife One" was developed to support the mobilization of the delivering women during the labor process. It consists of a mattress that fits on existing delivery beds.
- Trial name
- NCT03443349
- Testing
- Vibwife One
- Where
- Switzerland
- Volunteers
- 72 people
- Sponsor
- University Hospital, Basel, Switzerland
Medical Device, User-Computer Interface
The Monitoring Messenger: Mobile Patient Monitoring for the Pediatric Intensive Care Unit
The Mobile Messenger is a unified, portable and intelligent device that integrates information from multiple patient monitors, mechanical ventilators, infusion pumps and clinical information systems on a mobile platform.
- Conditions
- Medical Device, User-Computer Interface, Critical Care, Physiologic Monitoring
- Trial name
- NCT01612091
- Testing
- Monitoring Messenger, Traditional tools
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of British Columbia
Respiratory Distress Syndrome, Newborn, Medical Device Discomfort
Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment.
- Trial name
- NCT01526226
- Testing
- Respiratory support HFNC, Respiratory support NCPAP
- Where
- Norway
- Volunteers
- 24 people
- Sponsor
- University Hospital of North Norway
Contraceptive Devices, Intrauterine, Education, Medical
Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
Intrauterine devices (IUDs) are a very effective, long-acting method of contraception. In order to make them accessible to women, health care providers must be trained to insert them.
- Trial name
- NCT02220205
- Testing
- PelvicSim, Manufacturer model
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Medical Device Complication
Comparative Study of Baska & I-gel for Ventilation of Female Patients During Minor Procedures
The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) \& complications.
- Trial name
- NCT03140215
- Testing
- laryngeal mask insertion (Baska), laryngeal mask insertion (I-gel )
- Volunteers
- 60 people
- Sponsor
- Cairo University
Pulmonary Embolism, Medical Device Complication
Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis
- Trial name
- NCT02917135
- Testing
- Angel® Catheter
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- BiO2 Medical
Self Efficacy, Medical Device Complication
Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular aneurysms.
- Trial name
- CRANIAL-1 (NCT02830373)
- Testing
- LVIS stents
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Changhai Hospital
Self Efficacy, Medical Device Complication
Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.
- Trial name
- CRANIAL-2 (NCT02830386)
- Testing
- LVIS stent
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Changhai Hospital
Application Site Discomfort, Medical Device Discomfort
Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic
Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain from an upper arm Tq can limit the ability to use regional anesthesia as the primary anesthetic for surgical procedures on the upper…
- Trial name
- NCT01829399
- Testing
- Bupivacaine with Epinephrine, Normal Saline
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Medical Device Complication
Feasibility Study of PrePex Device When Performed on Early Infants & Children Male Population by Physicians
The PrePex is a WHO prequalified medical device for adult male circumcision for HIV prevention. The Government of Rwanda was the first country to implement the PrePex and acts as the leading Center of Excellence providing…
- Trial name
- RMC-06 (NCT02281461)
- Testing
- Male circumcision using a non-surgical device
- Where
- Rwanda
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Rwanda
Vacuum Extraction, Obstetrical, Randomized Controlled Trials
a Randomized Multicenter Trial Comparing Vacuum Assisted Delivery With the New Device "iCUP" Versus the Reference Cup.
The hypothesis is that the new vacuum assisted delivery device iCup is more effective than the reference cup, in terms of maternal and newborn morbidities and functioning
- Conditions
- Vacuum Extraction, Obstetrical, Randomized Controlled Trials, Failures, Medical Device, Maternal Lesions
- Trial name
- ICUP (NCT01058200)
- Testing
- iCup, reference cup
- Where
- 6 sites in France
- Volunteers
- 668 people
- Sponsor
- University Hospital, Grenoble
Analytical Reproducibility of a Medical Device
Spartan FRX Project Reproducibility Study
The Spartan FRX CYP2C19 Test System (hereafter referred to as the 'FRX System') is a qualitative in vitro diagnostic test for the identification of a patient's CYP2C19 *2, *3 and *17 genotypes from genomic DNA obtained from…
- Trial name
- NCT01676298
- Testing
- Spartan FRX CYP2C19 Test System
- Where
- 3 sites in Canada
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Spartan Bioscience Inc.
Congestive Heart Failure, Medical Device
Use of Defibrillator Information in the Emergency Department
This is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason.
- Trial name
- NCT00708058
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ohio State University