RecruitingACTRN12605000669695

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

Evaluation of the PillCam ESO Capsule in the Detection of Esophageal Varices in Patients with liver disease- known or suspected for esophageal varices


Sponsor

Given Imaging Ltd., New Industrial Park, Yoqneam, Israel

Enrollment

30 participants

Start Date

Nov 15, 2005

Study Type

Observational

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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Interventions

This multi center study will assess the performance of the PillCam ESO Esophageal Capsule and the Given Diagnostic System in the diagnosis of esophageal varices as compared to EGD.

This multi center study will assess the performance of the PillCam ESO Esophageal Capsule and the Given Diagnostic System in the diagnosis of esophageal varices as compared to EGD.


Locations(1)

Australia

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ACTRN12605000669695