Status:
COMPLETED
Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance
Lead Sponsor:
Medtronic - MITG
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to support the development of Given® Diagnostic System applications.
Detailed Description
This clinical study is designed to support the development of new generations of the Given® Diagnostic System and Agile™ Patency System that will accomplish better visualization, better diagnostic cap...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subject's age is between 18-75 years.
- Subject is healthy.
- Subject agrees to sign the Informed Consent Form.
- Exclusion criteria
- Female subject is pregnant.
- Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
- Subject has a pacemaker or other implanted electro-medical device.
- Subject has undergone certain prior abdominal surgery of the gastrointestinal tract, (other than uncomplicated appendectomy or uncomplicated cholecystectomy) such as small bowel or colonic resection. This will be evaluated by the PI.
- Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
- Subject suffers from life threatening conditions.
- Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
1225 Patients enrolled
Trial Details
Trial ID
NCT00949208
Start Date
July 1 2008
End Date
August 1 2016
Last Update
August 5 2016
Active Locations (2)
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1
Rambam - Medical center
Haifa, Israel, 31096
2
Given Imaging Ltd
Yoqneam, Israel, 20692