“Evaluation of the PillCam™ESO Capsule in the Detection of Esophageal Varices (MA-37)

This study has been completed.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00481416
First received: May 30, 2007
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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


Condition Intervention
Esophageal Varices
Device: PillCam Eso

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Evaluation of the PillCam™ Eso Capsule in the Detection of Esophageal Varices

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Enrollment: 318
Study Start Date: December 2004
Study Completion Date: January 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481416

Locations
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
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Given Imaging Ltd.
Ethicon Endo-Surgery
Investigators
Principal Investigator: Glenn M Eisen, MD OHSU Portland, OR
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00481416     History of Changes
Other Study ID Numbers: MA-37
Study First Received: May 30, 2007
Last Updated: May 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
Esophageal Varices
PillCam Eso
Capsule Endoscopy
Given Imaging
Inscope

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Varicose Veins
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014