Text Size

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:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01267318
First received: December 26, 2010
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Given Imaging website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01267318     History of Changes
Other Study ID Numbers: RD-301
Study First Received: December 26, 2010
Last Updated: July 4, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013