Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481416
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2007-05-30
Brief Title:
Evaluation of the PillCamESO Capsule in the Detection of Esophageal Varices
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
Evaluation of the PillCam Eso Capsule in the Detection of Esophageal Varices
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MA-37
Brief Summary:
The purpose of the study is to access the accuracy of the PillCam Eso capsule in identifying the presence of suspected esophageal disease in patients undergoing surveillance or screening for esophageal disease by standard endoscopy
Detailed Description:
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 300000 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 persons 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
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 persons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None