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Study Title: Evaluation of PillCam® ESO 2 in Patients with Suspected Esophageal Pathologies
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: Jody Mooney
Phone: 206 341 0501 Ext.11452
Email: jody.mooney@vmmc.org
What is the Evaluation of PillCam® ESO 2 in Patients with Suspected Esophageal Pathologies study?
The purpose is to evaluate the accuracy of the esophageal capsule in detecting esophageal disorders and suspected Barrett’s Esophagus in adults. Barrett’s Esophagus is a condition in which the esophagus, the muscular tube that carries food and saliva from the mouth to the stomach, changes so that some of its lining is replaced by a type of tissue similar to that normally found in the intestine. This process is called intestinal metaplasia. While Barrett’s esophagus may cause no symptoms itself, a small number of people with this condition develop a relatively rare but often deadly type of cancer of the esophagus called esophageal adenocarcinoma. This type of cancer is associated with the condition gastro-esophageal reflux disease (GERD), which is often referred to as heartburn of acid reflux.
Up to 250 men and women at approximately 11 sites will take part in this study. We think that about 20 people will take part in the study at this site
There is a 0.7-3.5% (Low) chance that the capsule will not be passed naturally in a bowel movement. This may occur if you happen to have a narrowed part in your bowel (stricture), which has not been seen before. In case the capsule is not passed naturally in a bowel movement you may need to undergo an endoscopic procedure or surgery to remove the capsule. The potential for capsule impaction will be minimized by excluding anyone who has a history of bowel obstruction or who has had abdominal surgery
Who can participate?
The study population will consist of adults between the ages of 18 and above who have been on PPI for atleast 28 days, with suspected esophageal pathologies and suspected Barrett’s Esophagus.
Subjects with known strictures, history of dysphagia, known zenker's diverticulum, major abdominal surgeries, are excluded
What do I have to do as a study participant?
Study Summary:
The purpose is to evaluate the accuracy of the esophageal capsule in detecting esophageal disorders and suspected Barrett’s Esophagus in adults. Barrett’s Esophagus is a condition in which the esophagus, the muscular tube that carries food and saliva from the mouth to the stomach, changes so that some of its lining is replaced by a type of tissue similar to that normally found in the intestine. This process is called intestinal metaplasia. While Barrett’s esophagus may cause no symptoms itself, a small number of people with this condition develop a relatively rare but often deadly type of cancer of the esophagus called esophageal adenocarcinoma. This type of cancer is associated with the condition gastro-esophageal reflux disease (GERD), which is often referred to as heartburn of acid reflux.
Up to 250 men and women at approximately 11 sites will take part in this study. We think that about 20 people will take part in the study at this site
There is a 0.7-3.5% (Low) chance that the capsule will not be passed naturally in a bowel movement. This may occur if you happen to have a narrowed part in your bowel (stricture), which has not been seen before. In case the capsule is not passed naturally in a bowel movement you may need to undergo an endoscopic procedure or surgery to remove the capsule. The potential for capsule impaction will be minimized by excluding anyone who has a history of bowel obstruction or who has had abdominal surgery
Detailed Study Description:
(No information)
Study Design: Interventional
Phase of Study: n/a
Study Type: Interventional
Condition or Study Focus: Esophageal disorders and suspected Barrett’s Esophagus in adults
Intervention Type: PillCam ESO2 Capsule
Intervention Name: PillCam ESO2 Capsule
Gender: Male and Female
Age group: Interventional
Sponsor: Given Imaging, Ltd
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