Evaluation of Patients With Non-cardiac Chest Pain

NCT00476398 | Completed Phase 4

• 1 other identifier: 2005P001321
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Cardiac Chest Pain; Gastroesophageal Reflux Disease

Keywords

Capsule endoscopy; Wireless imaging; esophagus; stomach

Outcome Measures

Primary Outcomes (1)

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

  60 day

Study Arms (1)

Diagnostic capsule endoscopy

NO INTERVENTION

Patient with non-cardiac chest pain will undergo capsule endoscopy

Procedure: Capsule endoscopy

Interventions

Capsule endoscopy PROCEDURE

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

Diagnostic capsule endoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Julia J. Liu, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: January 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 10, 2009

Record last verified: 2009-09