Non-Cancer Clinical Trials

• The Chronicle Study: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals with Severe Asthma in the United States.

• ISCHEMIA: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

• No studies available at this time.

• LINX II: A Post-Approval Study of the LINX Reflux Management System
• RELIEF: A Prospective, Multicenter Study of Reflux Management with the LINX System for Gastroesophageal Reflux Disease after Laparoscopic Sleeve Gastrectomy

• The C-TRACT Trial: Chronic venous thrombosis: relief with adjunctive catheter-directed therapy
• BEST Trial: Best Endovascular vs Best Surgical Therapy in Patients With Critical Limb Ischemia
• TIDE (Best ancillary study): The Impact of Diabetes on REvascularization in BEST-CLI (TIDE)

• 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).

• Crest-2: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (Crest-2) Protocol
• CREST-H: Carotid Revascularization and Medical Management for Asymptomatic Carotid stenosis - Hemodynamics
• INSYTE: Management of Parkinson’s Disease
  Psychosis in Actual Practice

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

• IXT5: Intermittent Exotropia Study 5: A Randomized Clinical Trial of Overminus 9 Spectacle Therapy for Intermittent Exotropia

• 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.

• Percepta: Prospective Registry to Evaluate Percepta Bronchial Genomic Classifier Patient Data: The PERCEPTA Registry

• ASLeap (CAIN457FUS06): A randomized, double-blind, parallel-group, multicenter study of secukinumab to compare 300 mg and 150 mg at Week 52 in patients with Ankylosing Spondylitis who are randomized to dose escalation after not achieving inactive disease during an initial 16 weeks of open-label treatment with secukinumab 150 mg
• M16-011(Abbvie): A phase 3, randomized, double-blind, study comparing risankizumab to placebo in subjects with active Psoriatic Arthritis (PsA) who have a history of inadequate response to or intolerance to at least one disease modifying anti-rheumatic drug (DMARD) therapy
• Vectra: Prospective Outcomes Study: Vectra DA Guided Care Compared to Usual Care

• Zenith: Low profile AAA Endovascular Graft Clinical Study

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.