This trial is active, not recruiting.

Conditions melena, hematemesis, peptic ulcer hemorrhage, variceal hemorrhage
Treatment video capsule endoscopy (pillcam eso2)
Sponsor George Washington University
Collaborator Given Imaging Ltd.
Start date March 2011
End date June 2017
Trial size 50 participants
Trial identifier NCT01371591, GWIRB#: 080933


The investigators propose to study the use of video capsule endoscopy (VCE) in the emergency department (ED) for the early assessment of acute upper gastrointestinal hemorrhage (UGIH). This pilot study will investigate the concept that VCE can be used in the ED and is useful for the diagnosis and treatment of patients with suspected UGIH.

The specific endpoints that are planned include the following: (1) the detection of UGIH; (2) the presence of fresh blood; (3) and subject tolerance. An ED attending and an expert gastroenterologist will independently interpret the VCE and make determinations regarding the planned endpoints. Their respective determinations will be compared to each other and to subsequent esophagogastroduodenoscopy (EGD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Patients who present to the ED with signs and symptoms highly suggestive of upper gastrointestinal bleeding.
video capsule endoscopy (pillcam eso2) Pillcam Eso2
Administration of wireless video capsule in the ED.

Primary Outcomes

Can Video Capsule Endoscopy (VCE) diagnose Upper gastrointestinal hemorrhage (UGIH) in the Emergency Department (ED).
time frame: 24 hours
the presence of fresh blood
time frame: 24 hours
the site of the bleeding
time frame: 24 hours
the etiology of the bleeding
time frame: 24 hours
patient tolerance of test
time frame: 24 hours

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients greater than 18. - Patients presenting with actual or reported hematemesis or coffee ground emesis or melena. Exclusion Criteria: - Refusal to participate - Patient is hemodynamically unstable - People with dysphagia or another swallowing disorder - Pacemaker - Known or suspected gastrointestinal obstruction, stricture or fistula - Prisoners - Patient lacks the ability to give informed consent - High suspicion of pregnancy

Additional Information

Official title Pilot Study to Investigate the Use of Wireless Capsule Endoscopy for Emergency Department Patients With Suspected Acute Upper Gastrointestinal Bleeding
Principal investigator Andrew C Meltzer, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by George Washington University.