Evaluation of the PillCam ESO Capsule in the Detection of Esophageal Varices

Not Applicable

Recruiting

• Conditions: Patients with liver disease- known or suspected for esophageal varices; Other - Liver

• Registration Number: ACTRN12605000669695
• Lead Sponsor: Given Imaging Ltd., New Industrial Park, Yoqneam, Israel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patient Has prior endoscopic confirmation of esophageal varices and is undergoing surveillance endoscopy orHas signs/symptoms of chronic liver disease, without previous diagnosis of esophageal varices, with clinical indication to undergo esophagoscopy (or EGD) 2.Patient agrees and signs the Informed Consent Form. 3. Patient is prepared to undergo upper GI endoscopy.

Exclusion Criteria

1. Patient has dysphagia2. Patient has known Zenkers Diverticulum3.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 pacemakers or other implanted electro medical devices.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 conditions11.Patient is currently participating in another clinical study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy of the PillCam ESO capsule in identifying the presence of esophageal varices in patients undergoing surveillance or screening for esophageal varices by EGD.[]

Secondary Outcome Measures

Name	Time	Method
Grading of Esophageal varices by the PillCam ESO procedure and EGD.[];Identification of portal hypertension gastropathy by capsule endoscopy and EGD. [];PillCam ESO Capsule endoscopy findings in the esophagus.[];Esophagoscopy (or EGD) findings in the esophagus.[]