Clinical trials: Device
Spinal Cord Injury, Urinary Incontinence
Two Devices for Reflex Voiding Following Spinal Cord Injury
The purpose of this investigation is to evaluate methods in spinal cord injured individuals to improve reflex urination. Anal dilation will be investigated to reduce high urethral resistance and a vibrator on the patient's bottom…
- Trial name
- NCT00662207
- Testing
- Vibrator, Anal dilator
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- US Department of Veterans Affairs
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Hearing Loss, Sensorineural
Benefit of Assistive Listening Device for Lateralization
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver.
- Trial name
- NCT05072457
- Testing
- Roger On microphone, Roger Select microphone
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sonova AG
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)
Cardiac Event
Minimally Invasive Cardiac Output Monitoring Device
The overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device.
- Trial name
- NCT01675063
- Testing
- Retia Non-Invasive Sensors
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- University of Michigan
Gastric Outlet Obstruction
Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction
The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction…
- Trial name
- MAD (NCT00487552)
- Testing
- Cook Magnetic Anastomosis Device (MAD) with Stent
- Where
- 4 sites in Belgium, Italy and 1 more
- Volunteers
- 18 people
- Sponsor
- Cook Group Incorporated
Obstructive Sleep Apnea (OSA)
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance.
- Trial name
- NCT02214238
- Testing
- PAP device
- Where
- New Zealand
- Volunteers
- 49 people
- Sponsor
- Fisher and Paykel Healthcare
Fat Disorder
SlimShape Device for Abdominal Fat and Circumference Reduction
Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape device for non-invasive abdominal fat and circumference reduction.
- Trial name
- NCT02999763
- Testing
- SlimShape
- Where
- 4 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Kidney Diseases
Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)
This is a single center pilot study that is seeking to determine whether the use of the Fist Assist® device for 360 hours over 90 days by patients with advanced CKD prior to AVF surgery results in significant increases in…
- Trial name
- FACT (NCT04063787)
- Testing
- Fist Assist
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Chicago
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.
Cholangiopancreatography, Endoscopic Retrograde
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered…
- Trial name
- SAMISEN-B (NCT05129449)
- Testing
- Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 89 people
- Sponsor
- Olympus Europe SE & Co. KG
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Ocular Surface Disease
Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device
The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface…
- Trial name
- NCT04918823
- Testing
- Restasis
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Boston Sight
Opioid-Related Disorders, Opioid Dependence
An Innovative Intervention for OUD Treatment
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment.
- Conditions
- Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal
- Trial name
- Bridge (NCT04325659)
- Testing
- Bridge Device, Lofexidine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Nasal Polyps
12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or…
- Trial name
- NCT01623310
- Testing
- Fluticasone Propionate
- Where
- 16 sites in United States
- Volunteers
- 223 people
- Sponsor
- Optinose US Inc.
Lymphedema
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of…
- Trial name
- ACE (NCT01239160)
- Testing
- Flexitouch System, Hydroven FPR
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 238 people
- Sponsor
- Tactile Medical
Skin Condition, Skin Diseases
VIO Imaging for Skin Tissue Assessment (VISTA)
To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment.
- Conditions
- Skin Condition, Skin Diseases, Skin Lesion, Skin Abnormalities
- Trial name
- VISTA (NCT05619471)
- Testing
- VIO Imaging
- Where
- 2 sites in United States
- Volunteers
- 65 people
- Sponsor
- Enspectra Health
Pelvic Organ Prolapse
Pelvic Floor Repair Systems for Prolapse Repair
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for…
- Trial name
- PROPEL (NCT00638235)
- Testing
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 725 people
- Sponsor
- ASTORA Women's Health
Ulcerative Colitis
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
- Trial name
- SMART (NCT02155335)
- Testing
- Prefilled Syringe delivery of Golimumab, Smartject Device delivery of Golimumab
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
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