Clinical trials: Medical Device
Peripheral Arterial Disease
Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment
The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.
- Trial name
- NCT02556255
- Testing
- B-Laser™ Atherectomy Catheter
- Where
- 2 sites in Poland
- Volunteers
- 57 people
- Sponsor
- Eximo Medical Ltd.
Anemia, Diabetes
A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
1. Aim: The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices. 2.
- Conditions
- Anemia, Diabetes, Heart Disease, High Blood Pressure
- Trial name
- NCT01196533
- Testing
- Non invasive peripheral blood monitoring
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Cnoga Medical Ltd.
Polyp, Colorectal
Colorectal Polyp Clinical Decision Support Device Study
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
- Conditions
- Polyp, Colorectal, Colonoscopy
- Trial name
- CDSD (NCT04437615)
- Testing
- Colonoscopy, Clinical Decision Support Device
- Where
- United States
- Volunteers
- 2,379 people
- Sponsor
- Olympus Corporation of the Americas
Atrial Fibrillation, Bleeding
HEAL-LAA Clinical Trial
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation, Bleeding, Stroke
- Trial name
- HEAL-LAA (NCT05809596)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 45 sites in United States
- Volunteers
- 949 people
- Sponsor
- Boston Scientific Corporation
Cervical Cancer, Endometrial Cancer
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- Trial name
- NCT00610740
- Testing
- topical gemcitabine hydrochloride, therapeutic conventional surgery
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Gastric Procedures, Lung Resection Procedures
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic.
- Trial name
- NCT04544865
- Testing
- Staple Line Reinforcement
- Where
- 8 sites in United States
- Volunteers
- 240 people
- Sponsor
- Ethicon Endo-Surgery
Asthma
Comparing Maintenance of Device Mastery With Turbohaler© vs. Spiromax© in Healthcare Professionals naïve to Both Devices
This study is conducted to assess the ease of device mastery of a placebo SYMBICORT TURBOHALER vs a placebo Budesonide/Formoterol SPIROMAX device among healthcare professionals in-training (HCP).
- Trial name
- HCP-ELIOT (NCT02570425)
- Testing
- Training on BF Spiromax followed by SYMBICORT Turbohaler, Training on SYMBICORT Turbohaler followed by BF Spiromax
- Volunteers
- 516 people, healthy volunteers welcome
- Sponsor
- Research in Real-Life Ltd
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
CLN3-related Disorders, Non-CLN3 Related Low Vision
Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
Background: CLN3 involves vision loss observed around the preschool years, with eventual progression to blindness within 1-3 years.
- Trial name
- NCT04974307
- Testing
- OrCam MyEye 2
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Total Knee Arthroplasty
Comparison of Intraoperative Warming Devices
The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee…
- Trial name
- NCT00711867
- Testing
- VH2, Bair Hugger
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Mayo Clinic
Concussion, Traumatic Brain Injury
Concussion Device Audiological Measures
Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from…
- Trial name
- NCT02262507
- Testing
- Device Wearing
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Vulvar Vestibulitis, Vestibulodynia
Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief
The objectives of this pilot study are to demonstrate effectiveness of application of the Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk low level laser red diode light therapy device…
- Trial name
- NCT02204319
- Testing
- Cold laser
- Volunteers
- 10 people
- Sponsor
- ProHealth Care, Inc
Stroke, Plegia
Treatment of Chronic Stroke With AMES + EMG Biofeedback
The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after…
- Conditions
- Stroke, Plegia, Paresis, Cerebrovascular Accident
- Trial name
- AMES (NCT01116544)
- Testing
- AMES Therapy (assisted movement and enhanced sensation)
- Where
- 3 sites in United States
- Volunteers
- 46 people
- Sponsor
- AMES Technology
Skin Laxity
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
- Trial name
- NCT04721600
- Testing
- Evoke Radiofrequency Device
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- InMode MD Ltd.
Asthma
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device.
- Trial name
- NCT01012739
- Testing
- Indacaterol 150 μg via the Concept1 dry-powder inhaler, Indacaterol 60 μg via the Simoon dry-powder inhaler, Indacaterol 120 μg via the Simoon dry-powder inhaler
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Avascular Necrosis of Hip, Osteoarthritis, Hip
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
- Conditions
- Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis
- Trial name
- MMC (NCT03681639)
- Testing
- Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
- Where
- Germany
- Volunteers
- 45 people
- Sponsor
- Zimmer Biomet
Asthma
Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with…
- Trial name
- NCT02892019
- Testing
- Indacaterol acetate 75 μg, Indacaterol acetate 150 μg
- Where
- 29 sites in Belgium, Colombia and 9 more
- Volunteers
- 79 people
- Sponsor
- Novartis Pharmaceuticals
Xerostomia
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
The purpose of this research study is to test the effectiveness of treating dry mouth through water rehydration using this extra oral water pump/irrigation device.
- Trial name
- NCT04901507
- Testing
- The Voutia System
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Virginia Commonwealth University
Primary Open Angle Glaucoma
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.
- Trial name
- NCT02016898
- Testing
- Placement of the sponge, Mitomycin-C
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Duke University
Consciousness Disorders, Locked-In Syndrome
Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome
The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome…
- Trial name
- NCT02772302
- Testing
- mindBEAGLE EEG-based brain-computer interface
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital