Clinical Trials

The aim of this study is to evaluate the potential improvement in colonoscopy procedure outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.

The primary purpose of this study is to evaluate the safety of the Check-Cap C-Scan System.

This study comprises three sub-studies. The objective of sub-study 1 was to characterize the dose-response, efficacy, and safety of  upadacitinib compared to placebo in inducing clinical remission per Adapted Mayo score (using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity, excluding Physician's Global Assessment [PGA]) in subjects with moderately-to-severely active UC in order to identify the induction dose of upadacitinib for further evaluation in Phase 3 studies including Substudy 2.

The primary objective of Substudy 2 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg QD compared to placebo in inducing clinical ...

The purpose of this study is to determine if diverticulosis is associated with metabolic syndrome factors such as hypertension and obesity independently from fiber intake.

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 ...

The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. 

The purpose of this study is to create a EECs biobank, which would be available for use by investigators at Mayo Clinic and outside the institution who look for the possibility to therapeutically manipulate EEC type, number and hormone secretion rate.

The primary goals of this project will be to standardize and enhance recommendations for colonoscopy surveillance intervals across the divisions of GIH and CRS and throughout the clinic practice

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 ...

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

The purpose of this study is to compare the efficacy of a low-volume bowel preparation versus a high-volume bowel preparation for bowel cleansing on hospitalized patients undergoing colonoscopies.

The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.

The purpose of the study is to determine the efficacy of the Lonestar FAIMS platform in distinguishing adequately versus inadequately prepped patients by fecal headspace analysis of volatile organic compounds.

The purpose of this study is to determine baseline ophthalmologic parameters in a group of practicing endoscopists, to evaluate whether these parameters correlate with adenoma detection rates (ADR) and to construct a reproducible and widely applicable screening protocol that can be used to test the adequacy of visual parameters in practicing endoscopists.

The purpose of this research is to evaluate the accuracy of a medical device that has been developed to automatically find polyps (small growths) during colonoscopies. The device uses a computer to detect and highlight potential polyps from the usual video images made during a colonoscopy, and such detections will be visible to  the doctor during the regular colonoscopy procedure. This medical device is called Endoscopy Video Assistance for Colonoscopy (EVA-C). EVA-C, an investigational device, has been developed to assist the doctor in identifying possible polyps, but is not meant to replace their decision making. 

The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).

The purpose of this study is to assess the effectiveness and safety of GIC-1001, a new, orally-administered, colon analgesic drug, developed to manage visceral pain, as an alternative to sedation during a full colonoscopy.

The goal of this study is to compare, both clinically and from a cost-effectiveness perspective, virtual or CT-C (CT-Colonography) to standard CT scan and optical colonoscopy (OC). Virtual colonoscopy is a combination of a radiologic evaluation of the abdomen and pelvis with intra-colonic imaging. Previous research supports the concept that CT-C may be an effective substitute for the current OC and address limited compliance for surveillance for CRC survivors.

The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness. During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic. during this appointment, The C-Scan Track will be attached to the subject's back. Subjects then will be asked to swallow the C-Scan capsule ...

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent patients.

This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ...

The primary aim of the study is to compare safety and effectiveness of two methods of endoscopic resection of large colorectal polyps: cold snare EMR (without electrocautery) vs. hot snare EMR (with electrocautery).

Primary Aim

            We aim to evaluate: 1) the correlation between patient-reported rectal bleeding and stool frequency and health-related quality of life focused on fatigue, depression and anxiety, and work productivity; and 2) the correlation between the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.

Secondary Aims

We also aim to evaluate the correlation between the combination of clinical/PRO and the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.

The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.

The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).

The purpose is to investigate whether a simple additional treatment applied during colonoscopy (called 'soft' coagulation) can reduce the risk of recurrence of polyp at the area where the polyp was removed. After a large polyp is removed it is known that there is a 20% chance that a small recurrence of polyp occurs at the site of removal can occur within 5 months of the polyp being removed. This in theory will burn off tiny polyp tissue, which is usually not visible to the naked eye. This additional treatment may possibly reduce the risk of polyp recurrence.

The purpose of this study is to determine the value of CTA as a first-line diagnostic study in hemodynamically stable patients who present to the emergency room with signs of lower GI bleeding that will undergo colonoscopy with bowel preparation.

The primary aims of the study include determining the patient’s experience with colon capsule endoscopy (CCE) and the associated bowel preparation. In addition, the nursing staff experience with administration of the colon capsule will also be noted. Finally, the physician’s experience with interpretation of the colon capsule images. The secondary aim of this study is preliminary evaluation of the diagnostic yield of CCE compared to CT colonography (CTC).

The aims of this study are to increase the number of Black consultants at MCA, make a meaningful impact on interactions among staff, leadership, and patients, and increase the number of Black staff in leadership roles beyond Diversity and Inclusion efforts.

The primary aim of this study is to determine if there is any evidence of viral shedding within the gastrointestinal or pulmonary system in patients with a prior recent negative nasopharyngeal PCR test. This will be of critical importance to the practice of endoscopy during this pandemic as it will help:  1) determine if a pre-endoscopy testing strategy is adequate to ramp-up access to semi-urgent and eventually elective procedures, while allowing the decreased utilization of limited or costly personal protective equipment (e.g., N95 respirators) while still keeping the GI endoscopy staff safe; and 2) realize the false negative rate of pre-procedural testing, which is vital to inform procedural practice policy and operations.