Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00481416




Registration number
NCT00481416
Ethics application status
Date submitted
30/05/2007
Date registered
1/06/2007
Date last updated
31/07/2019

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
Secondary ID [1] 0 0
MA-37
Universal Trial Number (UTN)
Trial acronym
MA-37
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal Varices 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 -

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2005
Sample size
Target
Accrual to date
Final
318
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Oregon
Country [4] 0 0
Israel
State/province [4] 0 0
Haifa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic - MITG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ethicon Endo-Surgery
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00481416
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glenn M Eisen, MD
Address 0 0
OHSU Portland, OR
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00481416