N/A N=23 Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure
Concussion, Mild
Primary: Blast Explosive Waves Experienced During the Training — 4.11; 4.29; 4.20; 4.0 number of blasts
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=30 Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
Central Line
Primary: Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device — 12 Interviews
N/A N=62 Protection Against Potential Brain Injury During Competitive Football
Concussion
Primary: Determine Average Number of Hits Between Groups — 896.43; 795.40; 144.67; 145.85 number of hits
N/A N=197 Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Occupational Exposure to Radiation
Primary: Radiation Attenuation in Percentage (%) — 12; 91.5; 97.1 Percentage
N/A N=222 BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Prostate Cancer
Primary: Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure — 25; 18…
N/A N=25 Breast Cup Immobilization Device II (GCC 1047)
Breast Cancer
Primary: Breast Cup Immobilization Device II (GCC 1047) Feasibility — 25 Participants
N/A N=72 Concussion Prevention in Female Soccer Athletes
Concussion, Mild · Concussion, Brain
Primary: Pre-season to Post-season DTI Percentage Change — -0.17; -1.27; 0.45; 2.83 percentage of change
N/A N=49 Collision Warning Device for Blind and Visually Impaired
Hemianopia · Hemianopsia · Peripheral Visual Field Defect
Primary: Number of Collision Incidents (All Contacts) — 13.79; 9.26 Rate (contacts per 100 hazards per hour) — p=< 0.001
N/A N=236 Safety and Clinical Performance of the Protecta ICD and CRT-D
Tachyarrhythmias · Heart Failure · Ventricular Dysfunction
Primary: Percentage of Subjects Who Are Inappropriate Shock Free — 98.5; 97.5 percentage of patients
N/A N=11 Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants
Plagiocephaly
Primary: Safety of Use of the Premie Pouch in VLBW Infants — 0 participants
N/A N=410 Concussion Device Audiological Measures
Concussion · Traumatic Brain Injury
Primary: Number of Participants Undergoing Acoustic Reflectance — 410; 410 participants — p=<0.05
N/A N=504 Protecta Smart Analysis Register
Patients With an Indication for an ICD Implantation According to the Guidelines
Primary: Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. — 94.9 % of episodes wo shock due to SmartShock
N/A N=55 A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
Hearing Impairment
Primary: Number of Participants With Skin Erythema After Device Application — 10; 10; 15; 14 Participants
N/A N=10 Demonstration of a New Device to Measure the Force of Delivering a Baby
Full Term Singleton Pregnancy
Primary: Force Exerted on a Fetus as the Delivery Occurs — 274.5 ounces
N/A N=79 An Isolation Device to Contain Aerosol During Aerosol Generating Procedures in the Operating Room
Aerosol Containment · Aerosol Generating Procedure
Primary: Particle Count Measurements During Intubation — 4026; 411; 105; 392 particles/cm^3 — p=<0.001
Phase 4 N=1,018 PROTECT Continued Access Post Marketing Surveillance Trial
Coronary Artery Disease, Autosomal Dominant, 1
Primary: To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation — 1.2…
N/A N=25 Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
Respiratory Tract Infections
Primary: RD19 Acceptability — 1; 0; 1; 9 Participants
N/A N=15 Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
Balance
Primary: Center of Mass Displacement (Sway) During Standing — .62 centimeters
Phase 4 N=126 Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
ST-segment Elevation Myocardial Infarction
Primary: Postinfarct Remodeling — 11; 6 Number of participants with remodeling
N/A N=30 Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Pain · Vision Nearsighted
Primary: Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain. — 0 Participants
N/A N=164 UV Exposure Assessed With Wearable Sensor and Sun Protection
Sunburn, Erythema · Sun Protection
Primary: Acceptability of Wearing UV Sensor and Receiving Text Messages — 22; 39.1; 40.1; 40.6 score on a scale — p=<0.01
N/A N=7 Evaluation of the Safety and Efficacy of the BioProtect Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
Prostate Cancer
Primary: Safety of Balloon Implant — 0 Participants
N/A N=106 New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)
Occupational Exposure to Radiation
Primary: Percentage Change — 79.7; 71.9 percentage change
N/A N=118 Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100
Allergic Sensitization
Primary: Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation — 110 Participants
N/A N=383 Neuroprotection in Patients Undergoing Aortic Valve Replacement
Aortic Stenosis · Brain Infarction · Cerebrovascular Accident
Primary: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction — 74.4; 68.0; 67.6 percentage of participants — p=0.22
N/A N=3,000 PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Stroke
Primary: The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) — 34; 43 Participants
N/A N=664 MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Breast Cancer
Primary: The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue…
N/A N=262 Proximal Protection With The Mo.Ma Device During Carotid Stenting
Carotid Artery Disease
Primary: Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure. — 0; 6; 0; 0 participants — p=<0.05
N/A N=388 Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
N/A N=4 Active Powered Prosthesis (APEX) for Spinal Cord Injury
Spinal Cord Injuries
Primary: User Ability to Operate the APEX Device — 4; 4 Participants