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Evaluation of Patients With Non-cardiac Chest Pain

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00476398
Enrollment
40
Registered
2007-05-22
Start date
2006-01-31
Completion date
2009-06-30
Last updated
2009-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease, Non-Cardiac Chest Pain

Keywords

Capsule endoscopy, Wireless imaging, esophagus, stomach

Brief 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.

Detailed 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.

Interventions

PROCEDURECapsule endoscopy

Patient will undergo a capsule endoscopy for the evaluation of their chest pain.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
endoscopy for evaluating the prevalence of esophago-gastric lesions in patients60 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026