Clinical Trials and Research

Clinical Trials and Research

Sofi participates and is a leader in performing research in the gastroenterology field.

LESS GERD Endostim Study

The EndoStim system is a new, minimally-invasive approach to treating gastroesophageal reflux disease (GERD) by neurostimulation. GERD occurs when stomach acid or other stomach contents flow back into the esophagus, often caused by a weak valve, or sphincter, between the esophagus and the stomach. The backwash (reflux) irritates the lining of the esophagus and causes GERD. The EndoStim system is designed to restore the function of this sphincter. The procedure is designed to be uniquely gentle – to keep your anatomy intact and reduce or avoid chances of gastro-intestinal side effects.

Most individuals with GERD are successfully treated with acid blocking medications called proton pump inhibitors (PPI), such as Nexium, Prevacid or Prilosec. However, nearly 30 percent of individuals on PPI medication continue to suffer from symptoms. If you are taking PPI medications every day but your symptoms do not completely go away, or if you experience side effects from the medication, you may be eligible for the LESS GERD trial.

ROARS (Registry of Outcomes from AntiReflux Surgery)

This registry collects information about standard antireflux surgical treatment options in everyday clinical practice to better understand the disease and develop better methods to treat it so we may improve patient care.

CALIBER

Now enrolling: We are the first site in the country and the only site in the Rocky Mountain region to start enrolling patients in the CALIBER study which is a randomized study look at the LINX device compared to taking reflux medications.

Enterra neurostimulator

This device for gastroparesis is placed under a protocol because it is for compassionate use.

STAR registry

This is a study sponsored by the American Gastroenterology Association to evaluate the Esophyx/TIF procedure compared to the traditional laparoscopic fundoplication.

Closed Studies

LINX with hiatal hernia

SOFI is now enrolling patients for this study.We are participating in a multi center study to look at the use of the LINX Reflux Management System in patients with moderate sized hiatal hernias. We are again the only site in the Rocky Mountain Region to be able to offer this study.

RESPECT

This is a randomized placebo controlled trial to look at the efficacy of the Esophyx device. This study is now closed. Click below to read the results.

Registry

This is an ongoing evaluation of patients that have had the Esophyx/TIF procedure to see how they are doing long term. This study is now closed.

LINX post market analysis

We are the only site in the Rocky Mountain Region that was asked to participate in a study to evaluate patients long term who have had the LINX device placed. This is a requirement by the FDA after approving the device for use. This study is now closed.

Prospective study- This is an ongoing study to evaluate all aspects of our care, from testing and diagnosis to outcomes of surgery. By carefully evaluating our data, we are able to improve outcomes, establish quality control, and publish our information.

Publications

To see all publications click here.