Clinical trial NCT00481416: "Evaluation of the PillCam™ESO Capsule in the Detection of Esophageal Varices
Official title: Evaluation of the PillCam™ Eso Capsule in the Detection of Esophageal Varices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Varices
Keywords: Esophageal Varices
PillCam Eso
Capsule Endoscopy
Given Imaging
Inscope
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Ethicon Endo-Surgery
First posted: 2007-06-01
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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 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.

Eligibility criteria: Inclusion Criteria:

1. Patient has prior endoscopic confirmation of esophageal varices and is undergoing surveillance endoscopy or
2. Patient has sign/symptoms of chronic liver disease, without previous diagnosis of esophageal varices,with clinical indication to undergo esophagoscopy (or EGD)

Exclusion Criteria:

1. Patient has difficulty swallowing
2. Patient has known Zenker's Diverticulum
3. Patient went through previous endoscopic treatment of esophageal varices
4. Patient is known or is suspected to suffer from intestinal obstruction
5. Patient has a cardiac pacemaker or other implanted electro medical device
6. Female patient is pregnant
7. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
8. Patient has had a prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy)
9. Patient has any condition, which precludes compliance with study and/or device instructions
10. Patient suffers from life threatening conditions
11. Patient is currently participating in another clinical study -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Plymouth
country: United States
facility: Minnesota Gastroenterology Associates
state: Minnesota
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: OHSU Portland, OR
name: Glenn M Eisen, MD
role: PRINCIPAL_INVESTIGATOR
References: