NCT01267318

Brief Summary

Development of a new diagnostic detection tool for gastrointestinal bleeding.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

December 26, 2010

Last Update Submit

July 29, 2019

Conditions

Keywords

Gastric juiceStomachGIGastric juice samples with presence of blood.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subject is either not competent or not willing to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM Medical Center

Haifa, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric juices content suctioned from patients routinely during the course of Gastroscopy.

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rami Eliakim, Prof.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2010

First Posted

December 28, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 31, 2019

Record last verified: 2012-07

Locations