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CompletedNCT00476398Updated Sep 10, 2009

Evaluation of Patients With Non-cardiac Chest Pain

A Phase 4 interventional study of Capsule endoscopy in Non-Cardiac Chest Pain and Gastroesophageal Reflux Disease, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-09-10.

Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-Cardiac Chest Pain
  • Gastroesophageal Reflux Disease

Keywords

  • Capsule endoscopy
  • Wireless imaging
  • esophagus
  • stomach
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    Diagnostic capsule endoscopy

    Patient with non-cardiac chest pain will undergo capsule endoscopy

    Procedure: Capsule endoscopy

Interventions

  • ProcedureCapsule endoscopy

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

06

What researchers measure

Primary outcomes

  1. endoscopy for evaluating the prevalence of esophago-gastric lesions in patients

    Time frame: 60 day

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00476398
Lead sponsor
Brigham and Women's Hospital
First posted
May 22, 2007
Start date
Jan 2006
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Sep 10, 2009

Study contacts

Julia J. Liu, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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