Monterey and Salinas, California              831/375-3577       

Monterey Bay GI Consultants Medical Group Inc.

Monterey Bay GI Research Institute Inc.

We are pleased to invite patients to participate in 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 may 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. Daniel Luba
Dr. Daniel 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 a fellowship in Gastroenterology at Stanford University Medical Center.  He is Board-certified in Gastroenterology. He has a special interest in Lynch and Familial Polyposis Syndromes.

Dr. Lloyd R. Garren
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 as a partner. 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 Hell
Dr. Richard 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 Cenified 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 and published, scientific abstracts on reflux provoking activities and acid exposure in correlation to Barrett's Esophagus length. He is certified in the National Institute's  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
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.

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 Gl 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.
BARRX Halo Registry:
HALO Patient Registry: Ablation of Barrett's Esophagus
Clinical Protocol #B-soo-052
PI: James A DiSario, M.D.
Co-Investigator: Daniel G. Luba, M.D.
Start date: August 14, 2008
Status: Closed to Enrollment

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 fficerative Colitis Clinical Study Protocol: #2007021-PGPo29
PI: James A DiSario, M.D.
Co-Investigator: Daniel G. Luba, M.D.
Start Date: May 3, 2007
End Date: September 2, 2009
Status: Closed to enrollment

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

Abbott HUMIRA Adalimumab International
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A 5-Year Non- interventional Registry Study ofHUMIRA (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:. Closed

Shire Pharmaceutical Development, Ltd.
A Phase ill 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, M.D.; Richard W. Hell, M.D.; Kathryn A. Swanson, M.D.
Start Date: September 23, 2009
Activation Date: October 8, 2009
Status: Closed

Outcomes of Cholangioscopyin a Community Hospital
Clinical Research Protocol: JADDGL: Cholangio 1
CHOMP IRB Registration ~ooo04326
PI: James A. DiSario, M.D.; Daniel G. Luba, M.D.
Co-Investigators: None
Approval Date: May 5, 2009
Status:Closed

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

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: ACf11286
PI: James A. DiSario, M.D.
Start Date: November 2009
Status:. Closed

A Phase3
Randomized, Double-mind, Placebo Controlled Multicenter Study to Assess
The Efficacy and Safety of Budesonide Foam (2mg/2sml BID for 2 Weeks,
Followed bymgJ2sml QD for 4 weeks) Versus Placebo in Subjects with Active Mild to
Moderate fficerative Proctitis or Proctosigmoiditis
PI: James A. DiSario, M.D.
Page 5 of 6
Sub-Investigators: Richard W. Hell, M.D.; Daniel G. Luba, M.D.; Lloyd Garren, M.D.; Kathryn A. Swanson,
M.D.
Start Date: November 2009
Status: Closed

Outcomes of Enteroscopy in a Community Hospital
Principal Investigator: James DiSario, M.D.
Sub-Investigators; Daniel G. Luba, M.D.
Start Date: November 29, 2007
Activation Date: November 29, 2007
Status: Closed

Outcomes of Cholangioscopy in a Community Hospital
Principal Investigator: James DiSario, M.D.
Sub-Investigators: Daniel G. Luba, M.D.
Start Date: May 5, 2009
Activation Date: May, 2009
Status: Closed

Outcomes of Sessile Polypectomy using a Grasp
and Snare Technique through a Double-channel
Endoscope in a Community Setting
Principal Investigator: Daniel G. Luba, M.D.
Sub-Investigators: James A. DiSario, M.D.
Start Date: November 2, 2010
Activation Date: November 2, 2010
Status:Closed

Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous
Polyps and Cancer: The DeeP-C Study Investigational Plan Protocol2on-01
PI: James A. DiSario, M.D.
Sub-Investigators: Daniel G. Luba, M.D., Lloyd Garren, M.D.
Start Date: August 3, 2011
Activation Date: November 1, 2011
Status: Completed; no longer open to enrollment.

A prospective evaluation of the feasibility of process engineering intervention on the screening and testing of Lynch Syndrome in individuals with personal and/or family history of Lynch-associated cancers.    PI: Daniel G. Luba, M.D. and James A. DiSario, M.D.     Start Date:  August 1, 2013  Status:  Closed.