Active Clinical Trials at CHI Health

Study Name: Oral Bio-Film

Principals: Esther Rathjen, MSN RN, APRN-CCNS and David W. Voigt, MD

Category: Burn/Wound

Study Site: CHI Health St. Elizabeth

Study Name: Correlation Between Chlorhexidine Rinse Regiment and Oral
Bio-Film

Description: The purpose of this research study is to evaluate the
effectiveness of Chlorhexidine in reducing the amount of bacteria that
accumulates in a person's mouth during the day. The researchers are
interested in determining if a more frequent use of Chlorhexidine during
the day, may result in patient's experiencing less health complications
such as Pneumonia.

Study Name: Re-Energize 

Principal: David Voigt, MD    

Category: Burn/Wound

Study Site: CHI Health St. Elizabeth

Study Name: A randomized trial of External Glutamine to minimize thermal injury

Description: Glutamine is a substance normally made by the body and can be found in your diet. This substance is important to the immune system during illness and stress. We hope to determine if increased doses of Glutamine decreases mortality and hospital lengths of stay in burn patients.

Study Name: AEGIS-II

Principal: Steven Krueger, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

Study Name: Barostim Therapy for Heart Failure (BeAT-HF)

Principal: Anuj Jain, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The purpose of this trial is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects with heart failure, defined as New York Heart Association (NYHA) functional class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).

Study Name: Early Feasibility Study of the AccuCinch® Ventriculoplasty System

Principal: Omar Nass, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventriculoplasty System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy. 

Study Name: CHAMPION-AF

Principal: Himanshu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: CHAMPION-AF

Description: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Study Name: INTERRUPT-AF

Principal: Peter Gallagher, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.

Study Name: MAKE

Principal: Thomas Kleisli, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart - Lincoln

Description: This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

Study Name: METEORIC-HF

Principal Investigator: Steven Krueger, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo.

Study Name: MORE_CRT_MPP

Principal: Hussam Abuissa, MD

Category: Cardiovascular

Study Sites: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Study Name: Novartis TQJ203

Principal Investigator: Steven Krueger, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

Study Name: OPTION

Principal Investigator: Stephen Ackerman, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: This study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

Study Name: PIONEER-HF

Principal: Himanshu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Study Name: PRECISE

Principal: Jeff Carstens, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy, CHI Health Immanuel, CHI Health Lakeside, CHI Health Midlands, and CHI Health Mercy Council Bluffs

Description: The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD, to be performed in outpatient settings, including primary care and cardiology practices.

Study Name: RELIEVE-HF

Principal Investigator – Steven Krueger, MD

Category – Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description – This study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional class III or ambulatory class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Study Name: ROMA

Principal Investigator: Thomas Kleisli, MD

Category: Cardiovascular

Study Site: CHI Health Nebraska Heart – Lincoln

Description: The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.

Study Name: SOLOIST

Principal: Ahmed Aboeata, MBChB

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure. 

Study Name: VIVO

Principal: Eric Vander Woude, MD

Category: Cardiovascular

Study Site: CHI Health St. Elizabeth

Study Name: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction

Description: We are investigating the safety and effectiveness of the Zilver Vena Venous Stent placed in patients with symptomatic venous outflow obstructions in one iliofemoral venous segment. The results of the study will be compared to performance goals derived from the literature.

Study Name: WARRIOR

Principal: Arun Knamantha-Reddy, MBBS

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR).

Study Name: WATCH-TAVR/WATCHMAN

Principal: Himansu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: WATCH-TAVR, WATCHMAN for Patients with Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement.

Study Name: PROTECTED-TAVR

Principal: Himansu Agarwal, MD

Category: Cardiovascular

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement.

Study Name: C-TRACT

Principal: Rahul Razdan, MD

Category: DVT(Deep Vein Thrombosis)

Study Site: CHI Health St. Elizabeth

Study Name: Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial) (C-TRACT)

Description: :The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructivepost thrombotic syndrome (DIO-PTS).

Study Name: Humira Legacy- 10 year registry

Principal: Robert Kizer, MD

Category: Digestive Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Active Ulcerative Colitis

Description: We are participating in a registry to collect data on patients with moderate to severe ulcerative colitis that are taking Humira (Adalimumab).  

Study Name: NASH 747-303 REGENERATE

Principal: Sandeep Mukherjee, MD

Category: Digestive Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Study Name: Liver Disease Study

Description: Nonalcoholic steatohepatitis is when the liver is swollen and damaged from the build up of fat in the liver.  We are investigating the safety and efficacy of an oral drug to delay health-related conditions in patients with nonalcoholic steatohepatitis or evidence of liver fibrosis (damaged or scarred liver tissue).  

Study Name: M14-431

Principal: Robert Kizer, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Biologic Therapy.

Study Name: M14-433

Principal: Robert Kizer, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Conventional Therapies, but have not Failed Biologic Therapy.

Study Name: Nash 747-304

Principal: Sandeep Mukherjee, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH).

Study Name: EG-CL-101

Principal: Subhash Chandra, MD 

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.

Study Name: EG-CL-102

Principal: Subhash Chandra, MD 

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

Study Name: Blue-C

Principal: Rajani Rangray, MD

Category: Gastroenterology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

CHI Health participates in over 50 cancer clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use clinical trials to learn more about how to fight cancer. 

Search open cancer clinical trials.

Study Name: LUNAR

Principal: Hadi Zahra, MD

Category: Oncology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure.

Study Name: Waste Tissue II

Principal: Matthew Dilisio, MD

Category: Orthopedics

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: Understanding Periarticular Pathophysiology Through Surgical Waste Tissue. 

Study Name: CHRONICLE

Principal Investigator: Bryan Krajicek, MD

Category: Pulmonary

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

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

Study Name: GC2006

Principal Investigator: Bryan Krajicek, MD

Category: Pulmonary

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The purpose of the study is to determine if liquid alpha1-proteinase inhibitor (human) (liquid alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.

Study Name: GC2007

Principal Investigator: Rob Plambeck, MD

Category: Pulmonary

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: The purpose of the study is to determine if a high dose of IVIG plus SMT can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.

Study Name: ACTT

Principal Investigator: Jeffrey Macaraeg, MD

Category: Pulmonary

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

Study Name: GD001

Principal: Michael Feloney, MD, FACS

Category: Urology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Brief Summary: Semen Sample Collection and Processing for use in the Development of Prostate Cancer Diagnostic Tests.

A link is not available for this study.

Study Name: ACT

Principal: Michael Feloney, MD, FACS

Category: Urology

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Brief Summary: A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.

Study Name: 3D Printing on Maternal Fetal Bonding

Principal Investigator: John Cote, MD

Category: Women's Health

Study Site: CHI Health Lakeside - Omaha

Description: The purpose of this trial is to determine the effects of 3D printing technology on maternal fetal bonding compared to 2D/3D ultrasounds.

Study Name: P16-836 Endometriosis Registry

Principal Investigator: John Cote, MD

Category: Women's Health

Study Site: CHI Health Creighton University Medical Center - Bergan Mercy

Description: A Multicenter, Observational Cohort Study of Women Receiving Standard of Care (SOC) for the Treatment of Pelvic Pain Attributable to Suspected or Confirmed Endometriosis.