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.)
Information provided by (Responsible Party):
Given Imaging Ltd.
First received: December 26, 2010
Last updated: July 4, 2012
Last verified: July 2012
Development of a new diagnostic detection tool for gastrointestinal bleeding.
||Observational Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Gastric juices content suctioned from patients routinely during the course of Gastroscopy.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- Subject is either not competent or not willing to provide written informed consent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267318
|RAMBAM Medical Center
|Haifa, Israel |
Given Imaging Ltd.
||Rami Eliakim, Prof.
||Rambam Health Care Campus
No publications provided
||Given Imaging Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 26, 2010
||July 4, 2012
||Israel: Ministry of Health
Keywords provided by Given Imaging Ltd.:
Gastric juice samples with presence of blood.
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Digestive System Diseases