Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed

NCT ID: NCT01625585

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The small intestine has been, until recent years, a black box to gastroenterologists because it is difficult to see and reach. Radiological imaging provides little details of small intestinal mucosa. Capsule endoscopy, introduced in 2001, enables gastroenterologists to visualize the entire small intestine from within for the first time, but it is only a diagnostic tool. Single-balloon enteroscopy (SBE) is a new enteroscopy methods that use an overtube with one balloon or a spiral to help pleat bowel onto the endoscope and allow examination of the distal small bowel. This methods allow for biopsy, hemostasis, and other therapeutic interventions to be performed in the small bowel. Early reports have been promising; with 50-70% diagnostic yield for small bowel pathology reported in the literature. However, despite these promising results the impact SBE findings on patient outcomes is not clear.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obscure Gastrointestinal Bleeding

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Push-and-Pull Enteroscopy Single-Balloon-Enteroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Consecutive patients undergoing SBE for OGIB

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barnes Jewish Hospital/ Washington University

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SBEWashU 2012

Identifier Type: -

Identifier Source: org_study_id