Clinical trials: Medical Devices
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
Arrhythmias, Cardiac
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
- Trial name
- NCT01130896
- Where
- United States
- Volunteers
- 1,509 people
- Sponsor
- Johns Hopkins University
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Growth Hormone Deficiency
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
- Trial name
- CHOOSE (NCT01112865)
- Testing
- Genotropin Pen, MARK VII pen
- Where
- 23 sites in Czechia, Germany and 5 more
- Volunteers
- 120 people
- Sponsor
- Pfizer
Operative Surgical Procedures
Glottic View Using Supraglottic Devices in Pediatric Patients
Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices.
- Trial name
- NCT02532465
- Testing
- Air-Q, i-gel
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Senthil G. Krishna
Chronic Sinusitis
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
- Trial name
- INTACT (NCT00939471)
- Testing
- Relieva™ Balloon Sinuplasty™ System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Integra LifeSciences Corporation
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Respiratory Distress Syndrome
Comparative Effectiveness Study of Bubble CPAP Devices in the NICU
Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb.
- Trial name
- NCT02392806
- Testing
- Bubble CPAP- BabiPlus, Respiralogics, Bubble CPAP- B&B Bubbler, B&B Medical devices
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Marya Strand, MD
Pulmonary Disease, Chronic Obstructive
A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).
- Trial name
- NCT03979807
- Testing
- Olodaterol/Tiotropium Bromide, Umeclidinium/ Vilanterol
- Where
- United States
- Volunteers
- 11,296 people
- Sponsor
- Boehringer Ingelheim
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Supraventricular Tachycardia
Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in…
- Trial name
- NCT00979303
- Testing
- Intracardiac echocardiography and 3D navigational system
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Boston Children's Hospital
Pectus Excavatum
Multicenter Trial of Magnetic Mini-Mover for Pectus Excavatum
This study is a Phase 3, multicenter, non-randomized study to evaluate the safety and efficacy of the next-generation outpatient Magnetic Mini-Mover Procedure (3MP) in 15 patients aged 8-14 years for the correction of pectus…
- Trial name
- 3MP (NCT01327274)
- Testing
- Magnetic Mini-Mover Procedure (Magnimplant)
- Where
- 3 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Michael Harrison
Resuscitation
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation [PPV]) for resuscitation in the delivery room…
- Trial name
- NCT00443118
- Testing
- T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP, Self Inflating Bag without PEEP
- Where
- 11 sites in United States, Argentina and 3 more
- Volunteers
- 1,032 people
- Sponsor
- Edgardo Szyld
Anesthesia, Analgesia
Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.
Multi-center, prospective, open label, single arm post-market study to assess the real-world safety and efficacy of BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes used in an on-market…
- Trial name
- NCT05953363
- Testing
- BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 161 people
- Sponsor
- Becton, Dickinson and Company
Diagnostic and/or Interventional Radiology Procedures
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient…
- Trial name
- NCT01222104
- Where
- 10 sites in United States
- Volunteers
- 634 people
- Sponsor
- Abbott Medical Devices
Cough, Upper Respiratory Tract Infection
Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.
The purpose of this study is to determine if there is comparable efficacy between carbocisteine and a protective cough syrup from natural ingredients in children's cough due to upper respiratory tract infections (URTI) such as…
- Trial name
- URTI (NCT01968434)
- Testing
- protective cough syrup, carbocisteine cough syrup
- Where
- 4 sites in Israel
- Volunteers
- 150 people
- Sponsor
- Clalit Health Services
Duchenne Muscular Dystrophy
Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD
This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living…
- Trial name
- NCT03531788
- Testing
- Armon Ayura (Kinova), JAECO Wrex
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Roxanna Marie Bendixen
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
Cerebral Palsy
Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD).
- Trial name
- NCT06455930
- Testing
- Stand-on ride-on power mobility device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of North Florida