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Non-Cancer Clinical Trials

The multi-specialty research group supports research in:

Allergy/Asthma

  • Liberty: a randomized, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of dupilumab in children 6-12 years of age with uncontrolled asthma. Protocol number EFC14153
  • ANDHI: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on Standard of Care Treatment. Protocol Number: D3250C00045

Cardiology

  • HYBRID: Randomized Trial of Hybrid Coronary
    Revascularization Versus Percutaneous Coronary Intervention
  • CardioMEMS: CardioMEMS HF System Post Approval Study
  • MPP Post- Market: “MultiPoint Pacing™ Post Market Study (MPP PMS)”
  • ISCHEMIA: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

Endocrinology

  • PERL: A multicenter clinical trial of allopurinol to prevent GFR loss in type 1 diabetes

Gastroenterology

  • LINX II: A Post-Approval Study of the LINX Reflux Management System

Interventional Radiology

Internal Medicine

  • PNEAU-DAY: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU-DAY).

Neurosciences

  • Crest-2: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (Crest-2) Protocol
  • INSYTE: Management of Parkinson’s Disease
    Psychosis in Actual Practice
  • SMART study: A Prospective, Multicenter Study Assessing the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

Obstetrics

  • Markers of Preterm Birth study: Distinguishing an RNA expression pattern in blood that distinguishes women with preterm labor from women with full term labor.

Ophthalmology

  • Glaucoma: A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction

Orthopedics

  • Active Spacer: A Prospective Post-market Study to determine the effect of the Active Spacer on soft tissue balancing and patient reported outcomes measures (PROMs) in robotic-assisted total knee arthroplasty.

Pulmonary

  • NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
  • Percepta: Prospective Registry to Evaluate Percepta Bronchial Genomic Classifier Patient Data: The PERCEPTA Registry

Rheumatology

  • AWARE: Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis (AWARE). Closed to Enrollment.
  • Axial Spondyloarthritis (AS0006): Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Certilozumab Pegol in Subjects with Active Axial Spondyloarthritis (AxSpa) without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation. Closed to Enrollment.
  • Lupus Nephritis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis
  • Vectra: Prospective Outcomes Study: Vectra DA Guided Care Compared to Usual Care

Vascular

  • Zenith: Low profile AAA Endovascular Graft Clinical Study

If you are interested in getting additional information on a research study, please contact:

Jonean Thorsen, RN, CRC
(608) 775-7001 or (800) 362-9567, ext. 57001
jethorse@gundersenhealth.org

Christine Roraff, RN, CRC
(608) 775-7001 or (800) 362-9567, ext. 57001
cmroraff@gundersenhealth.org

Industry Sponsored Research

Clinical research at Gundersen vital to FDA approval process

For several years, Gundersen Health System has joined with other major medical centers to conduct research trials essential in determining the safety and effectiveness of new medicines and technologies. Many Gundersen departments have participated in these trials—among them Cardiology, Endocrinology, Family Practice, Internal Medicine, Neurology, Pediatrics, Pulmonary, Rheumatology and Urology.

The Clinical Research department is self-supporting. All or most clinical trial-related costs such as clinic visits, laboratory tests, study drugs or devices and patient stipends for time and travel expenses are paid for with funds provided by the sponsoring pharmaceutical or medical device companies.

All patient participation in clinical trials is voluntary. Some patients volunteer hoping to benefit from a promising new medication or treatment that is not yet approved by the Food and Drug Administration. Most patients also are motivated by a desire to help others by providing information that could increase understanding and lead to better treatments.

Love + Medicine

Every day, Gundersen Health System staff deliver great medicine plus a little something extra—we call it Love + Medicine.

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