Evaluation of Patients With Non-cardiac Chest Pain

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Evaluation of Patients With Non-cardiac Chest Pain Using PillCam Eso - a Wireless Imaging Capsule of the Esophagus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476398
• Other study ID #: 2005P001321
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2007
• Last updated: September 8, 2009
• Start date: January 2006
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out how common diseases of the esophagus can cause chest pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause of chest pain in patients that do not have heart problems. The study test is called PillCam Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso will be compared to findings during conventional upper endoscopy.

Description:

Non-cardiac chest pain (NCCP) is defined by recurrent episodes of retrosternal chest pain in the absence of significant cardiovascular disease after a thorough cardiac evaluation. It accounts for 2-5% of all emergency department visits. Studies examining the prevalence of esophago-gastric lesions in patients with NCCP referred to gastroenterologists have found esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of patients. Advances in endoscopic technologies, particularly, the introduction of the wireless video-capsule (PillCam Eso) allows for the possibility of direct visualization of the upper gastrointestinal tract in the emergency department. During capsule endoscopy, a patient will swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are transmitted to a computer. Findings of the PillCam Eso will be then compared to findings during conventional upper endoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18 to 80 years

• negative cardiac evaluation in the emergency department

• pre-established access to a primary care provider

• ability to give informed consent

Exclusion Criteria:

• known history of ischemic heart disease

• proton pump inhibitor therapy

• known or suspected obstructions or strictures in the gastrointestinal tract, including a history of Crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy.

• permanent pacemakers/defibrillators or other implantable wireless devices

• known pregnancy

• unstable medical conditions

• inability to follow instructions

• active psychiatric conditions that preclude participation in the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Non-Cardiac Chest Pain

Intervention

Procedure:
• Capsule endoscopy
Patient will undergo a capsule endoscopy for the evaluation of their chest pain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopy for evaluating the prevalence of esophago-gastric lesions in patients		60 day	No