Research

 

 

We are pleased to invite patients to participate in basic science research through the Monterey Bay GI Research Institute. We are involved in the development of innovative treatments and cures for gastrointestinal diseases, and our research institute allows patients the opportunity to be a part of the remedy for these types of disorders.

Patients who qualify for active research projects also have the chance to take advantage of new treatment options as soon as they are made available. The Monterey Bay GI Research Institute is dedicated to ethically finding new and improved healing methods for gastrointestinal illness. We welcome your interest, participation and referrals.

INVESTIGATORS

Dr. James A. Disario received his medical degree at Georgetown University School of Medicine in Washington, D.C. with extracurricular studies at Oxford University in the U.K. He did an Internal Medicine Internship at the Medical College of Virginia and Residency at Georgetown University Medical Center. He completed a Fellowship in Gastroenterology at the University of Arizona and had subsequent post-doctoral training in advanced therapeutic biliary and pancreatic endoscopy at the University of Amsterdam in the Netherlands. Dr. DiSario is Board Certified in both Internal Medicine and Gastroenterology.

Dr. DiSario served as a faculty member at the University of Utah Health Sciences Center for 16 years where he practiced gastroenterology, advanced therapeutic endoscopy, and was an accomplished researcher and teacher. He achieved the rank of Professor of Medicine with tenure and maintains an appointment as Adjunct Professor. He has authored numerous publications in medical journals and chapters in medical textbooks, and serves as a reviewer and editor for these publications.

Dr. DiSario has maintained an accomplished clinical and translational research career spanning 20 years. He has been awarded numerous research grants from the National Institutes of Health, the National Cancer Institute (NCI), American Society for Gastrointestinal Endoscopy, American College of Gastroenterology, and the pharmaceutical and medical device industries. He has developed and served as the principal investigator on investigator-initiated NCI-sponsored, pivotal pharmaceutical studies and he has lectured at the most prestigious medical meetings both and internationally and has presented original research domestically and globally.

Dr. DiSario joined the Monterey Bay GI Consultants Medical Group in 2006 and is a partner in practice at peak career. He currently serves as the Director of the Gastrointestinal Endoscopy Unit at the Community Hospital of Monterey Peninsula and is an investigator and research consultant for the Monterey Bay GI Research Institute.

Dr. Dan G. Luba is the managing partner of the Monterey Bay GI Consultants Medical Group, Inc., Medical Director of the Monterey Bay Endoscopy Center, Inc., and President of the Monterey Bay GI Research Institute, Inc. He attended Boston University Medical School, where he completed a six-year combined undergraduate and medical school program and received the Henry J. Bakst Award in Community Medicine. He completed his Internship, Residency, and Chief Residency in Internal Medicine at Boston VA Medical Center and subsequently moved to California to do a fellowship in Gastroenterology at Stanford University Medical Center. He is board-certified in Internal Medicine and Gastroenterology.

Dr. Lloyd R. Garren completed his medical training and practiced medicine at the Medical College of Pennsylvania. He later moved to Monterey, where he joined the Monterey Bay GI Consultants Medical Group and has been practicing medicine since 1996.

Dr. Garren very recently completed his National Institute’s of Health Good Clinical Practice training with emphasis on the protection of human participants in clinical research, and has begun serving as an investigator on active pharmaceutical projects in the treatment of gastrointestinal disease through the Monterey Bay GI Research Institute.

Dr. Richard W. Hell upon completing medical school at Saint Louis University, completed an internship and residency in Internal Medicine at Cedars-Sinai Medical Center/U.C.L.A. He did his Sub-specialty Fellowship in Gastroenterology at the University of Arizona in Tucson. He is Board Certified in Internal Medicine and Gastroenterology.

Dr. Hell received the Paul Rubenstein, M.D. Prize for Excellence in Resident Research while at U.C.L.A. and the Cedars-Sinai Standing Ovation for Quality Service Award, while involved with studies in various gastrointestinal conditions such as Ascites, Barrett’s esophagus, Reflux disease, colon polyps and liver research. He has authored published, scientific abstracts on reflux provoking activities and acid exposure in correlation to Barrett’s Esophagus length. He certified in the National Institute’s of Health Protection of Human Research Participant training in February of 2009 and has served as an investigator on several gastrointestinal research projects through the Monterey Bay GI Research Institute since its inception.

Dr. Kathryn A. Swanson completed her medical school education with an M.D. from the University of Chicago, Pritzker School of Medicine. She went on to complete an Internship and Residency in Internal Medicine at the University of California, San Francisco and following that, completed a 3-year Academic Gastroenterology and Therapeutic Endoscopy Fellowship at Stanford University Medical Center.

Dr. Swanson completed her National Institutes of Health Good Clinical Practice training in November of 2008 and joined the Monterey Bay GI Research Institute as a sub-investigator where she has served on several pharmaceutical research projects to help manage or cure gastrointestinal disease.

Ms. Maydeen M. Ogara, A.S., CCRP earned her degree in general sciences in 1998, while living in Salt Lake City, Utah. In 2007, she was recruited by the physicians of the Monterey Bay GI Consultants, Medical Group to join the practice and start up and head a clinical research program servicing the greater Monterey Bay area, with special emphasis on gastrointestinal disease. She is responsible for raising grant money to fund GI studies, budget and contract negotiations, the ethical conduct of research, and the integrity of the collected data.

Ms. Ogara is a nationally certified member of the Society of Clinical Research Associates (SOCRA) and joins the practice with over a decade of experience in federal National Institutes of Health (NIH), GI organization and industry sponsored clinical research and protocol management.

CURRENT PROTOCOLS
We are pleased to invite patients to participate in basic science research through the Monterey Bay GI Research Institute.

We are involved in the development of innovative treatments and cures for gastrointestinal diseases, and our research institute allows patients the opportunity to be a part of the remedy for these types of disorders. Patients who qualify for active research projects also have the chance to take advantage of new treatment options as soon as they are made available.

The Monterey Bay GI Research Institute is dedicated to ethically finding new and improved healing methods for gastrointestinal illness. We welcome your interest, participation and referrals.

All research projects that are currently active here can be accessed on the web at www.clinicaltrials.gov
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

  1. BARRX Halo Registry:
    HALO Patient Registry: Ablation of Barrett’s Esophagus
    Clinical Protocol #B-500-052
    PI: James A. DiSario
    Co-Investigator: Daniel G. Luba
    Start date: August 14, 2008
    Status: Currently enrolling

  2. Proctor and Gamble Company
    A Phase III Multi-Center, Investigator-blinded, Randomized 12-month, Parallel group, Non-inferiority Study
    to Compare the efficacy of 1.6 to 2.4g Asacol Therapy QD Versus Divided Dose (BID) in the Maintenance
    of Remission of Ulcerative Colitis
    Clinical Study Protocol: #2007021-PGP029
    PI: James A. DiSario
    Co-Investigator: Daniel G. Luba
    Start Date: May 3, 2007
    End Date: September 2, 2009
    Status: Closed to enrollment
    (Active treatment phase ongoing)

  3. AstraZeneca Pharmaceuticals
    Validation of patient-reported outcome measures for the assessment of GERD symptoms and their subsequent
    impact on patients with a partial response to PPI treatment in a two part multi-center phase IIA study including a
    four week randomized, double-blind, placebo-controlled parallel-group treatment period with AZD3355, 65mg
    bid as add-on treatment to a PPI
    Clinical Study Protocol # D9120C00027- AZD3355
    PI: James A. DiSario
    Co-Investigator: Daniel G. Luba
    Start Date: June 19, 2008
    Status: Closed to enrollment (site closeout visit December 30, 2008)

  4. Given Imaging NEWPS (Negative Endoscopy with Persistent Symptoms) Program
    Post- Market Research Study
    PI: Lloyd Garren
    Co-Investigators: James A. DiSario, Daniel G. Luba, Toby Katz, Isabelle Barnard, Richard Hell
    Kathryn Swanson, Mary Garren, Isabelle Barnard
    Start Date: August 28, 2008
    End Date: December 20, 2008
    Status: Closed to enrollment

  5. Salix Pharmaceuticals, Inc.
    A Phase III, Randomized Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety
    Of Rifaximin 550mg TID in the Treatment of Subjects with Non-Constipation Irritable Bowel Syndrome
    Clinical Research protocol #RFIB3008
    PI: Daniel G. Luba
    Co-Investigators: James A. DiSario, Kathryn Swanson
    Start Date: November 6, 2008
    End Date: November 17, 2009
    Status: Closed to enrollment

  6. Abbott HUMIRA Adalimumab International
    A 5-Year Non- interventional Registry Study of HUMIRA (Adalimumab) in Subjects with Moderately to Severely Active Crohn’s Disease (CD)
    PI: James A. DiSario, M.D.
    Co-Investigators: Richard Hell, M.D, Daniel Luba, M.D. Kathryn Swanson, M.D.
    Start Date: December 27, 2007
    Activation date: June 5, 2009
    Status: Active. Currently enrolling

  7. Shire Pharmaceutical Development, Ltd.
    A Phase III Randomized, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo over 104 weeks in the Prevention of Recurrent Diverticulitis
    Clinical Research Protocol: SPD476-313
    PI: Daniel G. Luba
    Co-Investigators: James A. DiSario, Richard W. Hell, Kathryn A. Swanson
    Start Date: September 23, 2009
    Activation Date: October 8, 2009
    Status: Active. Currently enrolling

  8. Outcomes of Cholangioscopy in a Community Hospital
    Clinical Research Protocol: JADDGL: Cholangio 1
    CHOMP IRB Registration #00004326
    PI: James A. DiSario/Daniel G. Luba
    Co-Investigators: None
    Approval Date: May 5, 2009
    Status: Active. Currently enrolling

  9. Outcomes of Enteroscopy in a Community Hospital
    CHOMP IRB Registration # 00004326
    Clinical Research Protocol: JADDGL: Entero2
    PI: James A. DiSario/Daniel G. Luba
    Co-Investigators: None
    Approval Date: August 4, 2009
    Status: Active. Currently enrolling

  10. Sanofi-Aventis
    A Randomized, double-blind, placebo-controlled study of the effect of a single injection of SAR164877
    (REGN475) on reduction of pain from chronic pancreatitis
    Clinical Research Protocol: ACT11286
    PI: James A. DiSario
    Co-Investigators: Richard W. Hell, Daniel G. Luba, Kathryn A. Swanson
    Start Date: November 2009
    Status: Active. Currently enrolling

 


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