NCT01625585

Brief Summary

The goal of the present study is to investigate the clinical outcomes of patients with gastrointestinal bleeding originating from the small intestine following diagnostic investigation with single balloon enteroscopy. We hypothesize that single balloon enteroscopy can arrive at a diagnosis and provide therapeutics in a majority of patients with gastrointestinal bleeding originating in the small intestine.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

10 months

First QC Date

June 19, 2012

Last Update Submit

October 14, 2013

Conditions

Obscure Gastrointestinal Bleeding

Keywords

Push-and-Pull EnteroscopySingle-Balloon-Enteroscopy

Outcome Measures

Primary Outcomes (1)

  • Recurrence of obscure gastrointestinal bleeding following single balloon enteroscopy

    The primary outcome is recurrence of gastrointestinal bleeding, defined as recurrent overt or occult gastrointestinal bleeding, hospitalization for gastrointestinal bleeding or acute blood loss anemia.

    4 years

Study Arms (1)

Consecutive patients undergoing SBE for OGIB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent SBE at Washington University Medical Center/ Barnes Jewish Hospital prior to 1/1/2011 were eligible for inclusion. There was no control group as this was a retrospective cohort study.

You may qualify if:

  • Patients with Obscure Gastrointestinal Bleeding undergoing SBE at Barnes Jewish Hospital

You may not qualify if:

  • Less than 3 months of follow up after SBE
  • The endoscope could not be advanced into the duodenum will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital/ Washington University

St Louis, Missouri, 63110, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2012

First Posted

June 21, 2012

Study Start

May 1, 2011

Primary Completion

March 1, 2012

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

US(1)