“Evaluation of the PillCam™ESO Capsule in the Detection of Esophageal Varices (MA-37)
|ClinicalTrials.gov Identifier: NCT00481416|
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : June 1, 2007
|Condition or disease||Intervention/treatment|
|Esophageal Varices||Device: PillCam Eso|
The procedure that is being evaluated in this study is an esophageal capsule which is part of the Given® Diagnostic System. This system has been developed for aiding the gastroenterologist in diagnosing small bowel diseases or disorders, as routine methods used today cannot explore the entire length of the small bowel in detail. It is currently available in more than 50 countries worldwide, including the Europe, USA, Canada, Central and South America, Australia and Asia. More than 300,000 capsules have already been ingested worldwide. In this study, a capsule developed and approved for the esophagus (food tube between the mouth and stomach) with two optical heads (mini cameras) will be used and intended to take better recorded pictures of the esophagus.
During the study the study participant will undergo a capsule endoscopy and an upper esophagoscopy. The method under investigation in this study is the capsule endoscopy.
The capsule endoscope is a small camera, about an inch long and less than half an inch wide, which you will be asked to swallow. The camera travels from a person’s mouth all the way through their stomach and intestines and is eventually passed in the stool. The camera has a light source (like a flash on a regular camera) and takes pictures of the esophagus. The pictures are sent to a recorder, about the size of a wallet, using electronic signals for 20 minutes while the wireless endoscope goes through your esophagus. The disposable capsule is passed in the stool in an average of 24 hours.
After the capsule endoscopy the study participant will undergo the esophagoscopy. An esophagoscopy is the standard method used to view the esophagus. It involves inserting a long flexible tube with a light and camera on the end (called an endoscope) through the mouth and down the throat and esophagus. It may also involve the use of a sedative.
The study involves approximately two-three clinic visits.
|Study Type :||Observational|
|Actual Enrollment :||318 participants|
|Observational Model:||Defined Population|
|Official Title:||Evaluation of the PillCam™ Eso Capsule in the Detection of Esophageal Varices|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||January 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481416
|United States, Arizona|
|Mayo Clinic Hospital|
|Scottsdale, Arizona, United States, 85259|
|United States, Minnesota|
|Minnesota Gastroenterology Associates|
|Plymouth, Minnesota, United States, 55446|
|United States, Oregon|
|Oregon Health Sciences University|
|Portland, Oregon, United States, 97239-3098|
|Royal Brisbane and Women's Hospital|
|Herston, Queensland, Australia, 4029|
|Rambam Medical Center|
|Principal Investigator:||Glenn M Eisen, MD||OHSU Portland, OR|