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Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance

This study has been completed.
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT00949208
First received: July 29, 2009
Last updated: August 4, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to support the development of Given® Diagnostic System applications.

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Assessment of new or modified features of the GDS presently under development [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Capsule transition time throughout the all GI tract segments & Improved visualization of the mucosa and sub-mucosal structures (mostly by capsule modification) [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Improved automatic pathology identification & bowel cleanliness - index score [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Accuracy of capsule localization & Pathology size determination [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify and evaluate any additional features beneficial to GDS applications. [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Enrollment: 1225
Study Start Date: July 2008
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of healthy volunteers who fulfill all the inclusion criteria and do not meet any of the exclusion criteria.
Criteria

Inclusion criteria

  1. Subject's age is between 18-75 years.
  2. Subject is healthy.
  3. Subject agrees to sign the Informed Consent Form.

Exclusion criteria

  1. Female subject is pregnant.
  2. Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
  3. Subject has a pacemaker or other implanted electro-medical device.
  4. 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.
  5. Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
  6. Subject suffers from life threatening conditions.
  7. Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949208

Locations
Israel
Rambam - Medical center
Haifa, Israel, 31096
Given Imaging Ltd
Yoqneam, Israel, 20692
Sponsors and Collaborators
Medtronic - MITG
Given Imaging Ltd.
Investigators
Principal Investigator: Yehuda Chowers, Prof. Rambam Health Care Campus
Principal Investigator: Ari Bergwerk, Dr. Given Imaging
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00949208     History of Changes
Other Study ID Numbers: RD-30 
Study First Received: July 29, 2009
Last Updated: August 4, 2016
Health Authority: Israel: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Medtronic - MITG:
Healthy people

ClinicalTrials.gov processed this record on September 23, 2016