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A Phase 2 Open Label, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Oral Contrast Agent, NX9, for the Delineation of Bowel Anatomy at CT Imaging with and without IV Contrast in Subjects with Cancer or GI Disease Typically Evaluated with CT (MVSS NXT001-19 IBD)
Rochester, Minn.
The purpose of this study is to collect safety, effectiveness and pharmacokinetics (in a subgroup of subjects) data on the use of NX9 as an oral CT contrast agent.
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Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Rochester, Minn.
The purpose of this study is to evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.
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Comparative Effectiveness of Virtual and Optical Colonoscopy for Colorectal (CRC) Surveillance
Rochester, Minn.
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.
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Development of Ultrasound-based Methods to Guide Therapeutic Management in Crohn’s Disease (CD)
Rochester, Minn.
The purpose of this study is to compare the effectiveness of ultrasound with magnetic resonance (MR) enterography in the diagnosing and monitoring of Crohn's disease.
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Multicenter, Prospective, Randomized Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease (BLINK)
Rochester, Minn.
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 ups along with a Quality of Life questionnaire at 12 month follow up. Concomitant medication and adverse events information will be collected baseline and 3-, 6-, 9- and 12 month follow ups.
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The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Rochester, Minn.
The purpose of this study is the evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
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