Gastroenterology and Hepatology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study to Evaluate Smartphone-based Digital Phenotyping for Relapse Prediction in Alcohol-associated Liver Disease

   Rochester, Minn.

   The primary aim of this study is to define a comprehensive digital phenotype that predicts risk for near-future relapse or relapse in alcohol use in patients with alcohol-associated liver disease.

   The secondary aim of this study is to assess the relationship between this digital phenotype and markers of disease severity outcome, including MELD score and readmission rates.

2. A Study to Evaluate Colorectal Polyps with Dietary Inflammation During Colonoscopy

   Jacksonville, Fla.

   Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States (1). Colorectal cancer arises from colonic polyps. The major types of polyps associated with colorectal cancer development are adenomatous (tubular which is most common and other types are villous and tubulovillous) and serrated (hyperplastic, sessile or traditional) polyps with varying degrees of dysplasia (2). Hyperplastic polyps are common but they have a low malignancy potential (3). There is evidence that colonic inflammation plays a major role in colon polyp and colorectal cancer development. For example, inflammatory bowel disease is a major predisposing factor for colorectal cancer occurrence, implicating inflammation in the development of colorectal cancer (4). In addition,  obesity, a chronic inflammatory state, is associated with increased colorectal cancer risk (5). However, the use of anti-inflammatory agents in the prevention of colorectal cancer is controversial, although there is some suggestion that its use may lower colorectal cancer risk (6,7). Diet may affect cytokine levels and inflammation (8). Diet rich in trans-fat and sugar has been shown to increase pro-inflammatory cytokines IL-6 and TNFα (9, 10) and the Mediterranean Diet has been shown to decrease inflammatory cytokines (11) and decrease the risk of colon cancer in an UK study (12). Recently, the EDII was developed and validated to assess inflammatory potential of diet based on the Food Frequency Questionnaire (FFQ) (13).  Here we propose to investigate the association between diet-derived inflammation, as measured by the EDII, risk of colon polyps during screening colonoscopy and colorectal cancer development.

3. A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

4. A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

   Rochester, Minn.

   The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

5. Pulmonary Rehabilitation in End-Stage Liver Disease

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

6. Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects

   Rochester, Minn.

   The purpose of this study is to assess the pharmacodynamics (PD) of HM15211 after administration of multiple subcutaneous (SC) doses compared to placebo on the liver by proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH Clinical Research Network (CRN) fibrosis score.

   Resolution of NASH is defined as non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of 0–1 for inflammation, 0 for ballooning, and any other value for steatosis

7. Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

8. Suturing Pattern for Endolumenal Stenting Procedures

   Rochester, Minn.

   The purpose of this study is to track endoscopically-placed stents and demonstrate that either suturing pattern is equivalent.

9. Study of Gastric Cancer and Limited Peritoneal Metastasis Using Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy

   Rochester, Minn.

   The purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.

10. A Study to Understand Crohn’s Disease using a Genetic Approach

    Rochester, Minn.

    The purpose of this study is to collect clinical information, blood and tissue samples from people with Crohn’s disease at the time of their bowel resection and at their standard of care colonoscopy after bowel resection. People without Crohn’s Disease are being asked only to give tissue samples at the time of a clinically indicated colonoscopy so their tissue can be compared to those that have Crohn’s Disease.

    This study will compare the genetic codes (DNA) from active disease affected intestinal cells to these same cells from the same patient when they are without disease (inactive). We will be able to conclude which genetic codes are modified in the setting of active and inactive CD. This study has hopes of understanding the root cause of Crohn’s Disease.