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Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure

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ClinicalTrials.gov Identifier: NCT01267318
Recruitment Status : Terminated (Sponsor decided to terminate the entire project, and therefore there was no use for the samples collected in the study.)
First Posted : December 28, 2010
Last Update Posted : July 6, 2012
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.

Brief Summary:
Development of a new diagnostic detection tool for gastrointestinal bleeding.

Condition or disease
Gastrointestinal Bleeding

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.

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


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.

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

Additional Information:
Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01267318     History of Changes
Other Study ID Numbers: RD-301
First Posted: December 28, 2010    Key Record Dates
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