Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance
1 other identifier
observational
1,225
1 country
2
Brief Summary
The purpose of this study is to support the development of Given® Diagnostic System applications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2008
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 29, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 5, 2016
March 1, 2016
8.1 years
July 29, 2009
August 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Assessment of new or modified features of the GDS presently under development
Within 7 Days
Capsule transition time throughout the all GI tract segments & Improved visualization of the mucosa and sub-mucosal structures (mostly by capsule modification)
Within 7 days
Improved automatic pathology identification & bowel cleanliness - index score
Within 7 days
Accuracy of capsule localization & Pathology size determination
Within 7 days
Secondary Outcomes (1)
Identify and evaluate any additional features beneficial to GDS applications.
within 7 days
Study Arms (1)
A
The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria.
Eligibility Criteria
The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria.
You may qualify if:
- Subject's age is between 18-75 years.
- Subject is healthy.
- Subject agrees to sign the Informed Consent Form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (2)
Rambam - Medical center
Haifa, 31096, Israel
Given Imaging Ltd
Yoqneam, 20692, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Yehuda Chowers, Prof.
Rambam Health Care Campus
- PRINCIPAL INVESTIGATOR
Ari Bergwerk, Dr.
Given Imaging
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2009
First Posted
July 30, 2009
Study Start
July 1, 2008
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 5, 2016
Record last verified: 2016-03