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Clinical Studies


  • An Integrated Metagenomics and Immunoproteomics Study of the Role of Microbiome in Pouchitis Development Scottsdale/Phoenix, Ariz.

    The primary purpose of this study is to establish an Arizona-based patient recruitment and sample collection infrastructure with a wide network of gastroenterologists in Maricopa County, including both academic and community gastroenterologists.  Secondarily, they will analyze the pouch microbiota and anti-microbial antibodies in longitudinal samples collected from patients undergoing RPC with IPAA.  We will compare data from patients who develop pouchitis and those who do not develop pouchitis to eventually identify antibody markers that can prognosticate pouchitis and understand the role of bacteria or immune response to them in pouchitis development. 

  • Prospective, Open Label, Pivotal Study of the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference Rochester, Minn., Scottsdale/Phoenix, Ariz.

    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).

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  • Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps Rochester, Minn., Scottsdale/Phoenix, Ariz. 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 and will be released from the clinic to their routine. Subjects will be asked to ingest contrast agent fluid and fiber pills starting 48 hours before capsule swallowing, up to capsule natural excretion. Standard colonoscopy procedure will be performed within 60 days following the C-Scan Cap swallowing.

Closed for Enrollment

  • A Multicenter Open-Label Extension Study to Assess Long-Term Safety of PF-00547659 in Subjects with Ulcerative Colitis (TURANDOT II) (TURANDOT II) Scottsdale/Phoenix, Ariz.

    Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 72 weeks of open-label treatment to evaluate the long-term safety of the drug.

  • A Phase 1b Multi-Center, Randomized, Double-Blind, Multi−Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD−1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis Scottsdale/Phoenix, Ariz.

    This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TD-1473 in subjects with moderately-to-severely active UC over 28 days. This exploratory study will also serve as a signal seeking endeavor to demonstrate biologic effect associated with TD-1473 through biomarker analysis and clinical, endoscopic, and histologic assessments.

  • A Prospective Study of the Patency Capsule and Radiologic Tests in Diagnostic Management of Patients with Suspected or Known Intestinal Strictures Scottsdale/Phoenix, Ariz.

    The purpose of our research study is to identify the usefulness and safety of patency capsule (PC) and compare with radiology tests such as CT enterography or MR enterography in patients with intestinal obstruction.

  • Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I (PUCCINI) Scottsdale/Phoenix, Ariz.

    Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery.

    By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases.

    If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.