Research

 

 

The purpose of the research institute is the development of a participant-based research program which will allow patients the opportunity to voluntarily participate in clinically sponsored and investigator-initiated research, with special focus on the most current drug and device technologies in the treatment of gastrointestinal disease.
Our mission is to advance medical knowledge and practice through ethical, clinical research projects involving diagnosis and treatment of digestive diseases utilizing leading edge medicines and technologies.
Our vision is to strive for excellence in gastrointestinal medicine to improve the lives of individuals in the local and greater community.
Our values are to respect and treat, with integrity, those who participate in research projects for the betterment of healthcare for the individual and society as a whole.

INVESTIGATORS
Dr. Dan G. Luba is the managing partner of Gastroenterology Consultants and the Monterey Bay Endoscopy Center.  He completed his medical education at Boston University, and did his Internship and Residency in Internal Medicine at Boston VA Medical Center in Boston, MA. Following that, Dr. Luba moved to California to do a fellowship in Gastroenterology at Stanford University Medical Center. He is Board Certified in Internal Medicine and Gastroenterology.

Dr. James A. Disario received his medical degree at Georgetown University School of Medicine in Washington, D.C.  He also participated in extracurricular studies at University of Oxford in England.  He completed an Internship in Internal Medicine at the Medical College of Virginia and a Residency in Internal Medicine at Georgetown University Medical Center.  He completed a Fellowship in Gastroenterology at the University of Arizona and other post-doctoral training in Advanced Therapeutic Biliary an Pancreatic Endoscopy at the University of Amsterdam, The Netherlands.  Dr. Disario has been a Medical officer for the U.S. Public Health Service and a Professor of Medicine at the University of Utah where he practiced Gastroenterology for sixteen years. Dr. Disario is Board Certified in both Internal Medicine and Gastroenterology and he has edited numerous medical journals,  books and has been awarded many research grants and honors in the field of Gastroenterology.  He has been a teacher and mentor for many graduate medical students and faculty and has presented medical education programs internationally.

Ms. Maydeen M. Ogara, CCRP is a clinical research specialist and general sciences associate. She earned her degree in 1998. She is a nationally certified member of the Society of Clinical Research Associates and joins the practice with nearly a decade of experience in clinical research protocol management.

CURRENT PROTOCOLS
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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