Clinical trials: Device
Surgery
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
- Trial name
- NCT01559506
- Testing
- Air Barrier System device
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Nimbic Systems, LLC
Prostate Cancer
Performance Evaluation of the AMS CONTINUUM™ Device
1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy. 2.
- Trial name
- NCT00894933
- Testing
- CONTINUUM™
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- American Medical Systems
Arthritis
PyroTITAN Humeral Resurfacing Arthroplasty (HRA)
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™…
- Trial name
- HRA (NCT02983292)
- Testing
- PyroTITAN™ HRA
- Where
- Australia
- Volunteers
- 137 people
- Sponsor
- Smith & Nephew, Inc.
Schizophrenia, Mental Disorder
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
- Conditions
- Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02219009
- Testing
- MIND1 System
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Mild Cognitive Impairment, Cognitive Impairment
Study of Nasal Insulin to Fight Forgetfulness - Device Study
The SNIFF Device study will involve using a device to administer insulin through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body.
- Trial name
- NCT03857321
- Testing
- Insulin, intranasal nebulizer-like device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Fall, Fear of Falling
Optimizing a Technology-based Body and Mind Intervention
Older adults may feel at risk for falling, but do not have a physical risk of falling. On the other hand, some older adults may not feel at risk for falling, but do have a physical risk of falling.
- Conditions
- Fall, Fear of Falling, Physical Inactivity, Sedentary Behavior
- Trial name
- NCT05778604
- Testing
- Physio-feedback, Cognitive reframing, Peer-led exercises
- Where
- United States
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- University of Central Florida
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.
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
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