Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000669695
Ethics application status
Approved
Date submitted
11/10/2005
Date registered
20/10/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the PillCam ESO Capsule in the Detection of Esophageal Varices
Scientific title
Evaluation of the PillCam ESO Capsule in the Detection of Esophageal Varices in Patients with liver disease- known or suspected for esophageal varices
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with liver disease- known or suspected for esophageal varices 817 0
Condition category
Condition code
Other 881 881 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 712 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1138 0
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.
Timepoint [1] 1138 0
Secondary outcome [1] 2099 0
Grading of Esophageal varices by the PillCam ESO procedure and EGD.
Timepoint [1] 2099 0
Secondary outcome [2] 2100 0
Identification of portal hypertension gastropathy by capsule endoscopy and EGD.
Timepoint [2] 2100 0
Secondary outcome [3] 2101 0
PillCam ESO Capsule endoscopy findings in the esophagus.
Timepoint [3] 2101 0
Secondary outcome [4] 2102 0
Esophagoscopy (or EGD) findings in the esophagus.
Timepoint [4] 2102 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 971 0
Commercial sector/Industry
Name [1] 971 0
Given Imaging Ltd.
Country [1] 971 0
Israel
Primary sponsor type
Commercial sector/Industry
Name
Given Imaging Ltd., New Industrial Park, Yoqneam, Israel
Address
Country
Israel
Secondary sponsor category [1] 839 0
None
Name [1] 839 0
Nil
Address [1] 839 0
Country [1] 839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2276 0
Royal Brisbane Hospital
Ethics committee address [1] 2276 0
Ethics committee country [1] 2276 0
Australia
Date submitted for ethics approval [1] 2276 0
Approval date [1] 2276 0
Ethics approval number [1] 2276 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35267 0
Address 35267 0
Country 35267 0
Phone 35267 0
Fax 35267 0
Email 35267 0
Contact person for public queries
Name 9901 0
Melissa Cohen
Address 9901 0
Given Imaging Pty Ltd
Unit 4
Rydelink Business Park
277 Lane Cove Road
North Ryde NSW 2113
Country 9901 0
Australia
Phone 9901 0
+61 2 98893944
Fax 9901 0
+61 2 98893955
Email 9901 0
melissa@givenimaging.com
Contact person for scientific queries
Name 829 0
Melissa Cohen
Address 829 0
Given Imaging Pty Ltd
Unit 4
Rydelink Business Park
277 Lane Cove Road
North Ryde NSW 2113
Country 829 0
Australia
Phone 829 0
+61 2 98893944
Fax 829 0
+61 2 98893955
Email 829 0
melissa@givenimaging.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.