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Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure

This study has been terminated.
(Sponsor decided to terminate the entire project, and therefore there was no use for the samples collected in the study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01267318
First Posted: December 28, 2010
Last Update Posted: July 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Given Imaging Ltd.
  Purpose
Development of a new diagnostic detection tool for gastrointestinal bleeding.

Condition
Gastrointestinal Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Biospecimen Retention:   Samples With DNA
Gastric juices content suctioned from patients routinely during the course of Gastroscopy.

Enrollment: 5
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:
Literature does not support enough data/knowledge regarding stomach bleeding Hb levels in pathological situations and/or stomach bleeding levels following biopsy. It is important to understand the approximate concentration level of stomach bleeding before proceeding with technology development to insure this technology is capable of detecting such blood levels.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All gastric juice samples should contain blood. This will be determined by the treating physician based on visual assessment in a region alongside the fresh biopsy site just performed, and prior to any saline washing.
Criteria

Inclusion Criteria:

  • Male or female subjects ≥ 18 years old.
  • Subject is scheduled for EGD endoscopy which includes biopsy, or,
  • Subject is scheduled for EGD endoscopy following a bleeding event.

Exclusion Criteria:

  • Subject is either not competent or not willing to provide written informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267318


Locations
Israel
RAMBAM Medical Center
Haifa, Israel
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Rami Eliakim, Prof. Rambam Health Care Campus
  More Information

Additional Information:
Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01267318     History of Changes
Other Study ID Numbers: RD-301
First Submitted: December 26, 2010
First Posted: December 28, 2010
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by Given Imaging Ltd.:
Gastric juice
Stomach
GI
Gastric juice samples with presence of blood.

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes