Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure

July 29, 2019 updated by: Medtronic - MITG
Development of a new diagnostic detection tool for gastrointestinal bleeding.

Study Overview

Status

Terminated

Conditions

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

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Rami Eliakim, Prof., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 26, 2010

First Submitted That Met QC Criteria

December 27, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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