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Study Title: RG1068 (Synthetic Human Secretin) – Enhanced MRCP in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis
Category: Gastroenterology

Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.

Principal Investigator: Richard Kozarek
Study Coordinator: Alice Stead
Phone: 206 341 0501 Ext.11450
Email: alice.stead@vmmc.org

What is the RG1068 (Synthetic Human Secretin) – Enhanced MRCP in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis study?

Secretin is a naturally occurring peptide hormone that rapidly promotes the movement of pancreatic fluid into the pancreatic ducts, and thereby enhances the magnetic resonance imaging (MRI) signal, and improves the delineation of both normal and abnormal duct structures. The goal of this clinical study is to demonstrate that RG1068, a synthetic human secretin, in conjunction with MRCP provides an improvement in diagnostic utility compared to unenhanced MRCP for subjects with pancreatic duct abnormalities.This phase III trial is being undertaken to confirm that RG1068 enhances the sensitivity of MRCP in detecting pancreatic duct abnormalities without loss of specificity, using an ERCP-based truth standard.

Who can participate?

Inclusion: Patient 18 and above with known or suspected esophageal disease & recent symptoms of GERD or Barretts; and currently taking PPI for at least 28 days.

Exclusion: Patient with dysphagia, known zenker's diverticulum, known or suspected esophageal &/or intestinal obstruction.

What do I have to do as a study participant?

Study Summary:

Secretin is a naturally occurring peptide hormone that rapidly promotes the movement of pancreatic fluid into the pancreatic ducts, and thereby enhances the magnetic resonance imaging (MRI) signal, and improves the delineation of both normal and abnormal duct structures. The goal of this clinical study is to demonstrate that RG1068, a synthetic human secretin, in conjunction with MRCP provides an improvement in diagnostic utility compared to unenhanced MRCP for subjects with pancreatic duct abnormalities.This phase III trial is being undertaken to confirm that RG1068 enhances the sensitivity of MRCP in detecting pancreatic duct abnormalities without loss of specificity, using an ERCP-based truth standard.

Detailed Study Description:

(No information)

Study Design: Interventional
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Acute or acute recurrent pancreatitis
Intervention Type: RG1068 (Synthetic Human Secretin)
Intervention Name: RG1068
Gender: Male and Female
Age group: Interventional
Sponsor: Given Imaging, Ltd

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