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In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00737802
First received: August 18, 2008
Last updated: August 19, 2008
Last verified: August 2008
History of Changes
  Purpose

The purpose of this study is:

  • To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.
  • To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.

Condition
GERD

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Pressure at the gastric sling and clasp fibers [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2005
Groups/Cohorts
1
Normal control subjects without GERD
2
Patients with GERD.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal control subjects without GERD and patients with GERD

Criteria

Inclusion Criteria:

Inclusion criteria for GERD patients are:

  • Symptomatic heartburn
  • Regurgitation
  • Chest pain or water brash

Exclusion Criteria:

Exclusion criteria for normal volunteers include:

  • Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.
  • GI symptoms, conditions and disorders

In addition exclusion criteria will include a history of:

  • Esophagitis
  • Gastrointestinal symptoms such as abdominal pain
  • Heartburn
  • Reflux
  • Regurgitation
  • Chest pain
  • Difficulty swallowing
  • Pain on swallowing
  • Dysphagia
  • Abdominal surgery involving the stomach or esophagus
  • Nausea or vomiting
  • Diabetes
  • Scleroderma
  • Esophageal motility disorders
  • Non cardiac chest pain
  • Achalasia and current pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737802

Contacts
Contact: Larry Miller, M.D. 215-707-6922 vivi@temple.edu

Locations
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19040
Contact: Larry Miller, M.D.     215-707-6922     vivi@temple.edu    
Principal Investigator: Larry Miller, M.D.            
Sponsors and Collaborators
Temple University
  More Information

No publications provided

Responsible Party: Larry Miller M.D./Principal Investigator, Temple University
ClinicalTrials.gov Identifier: NCT00737802     History of Changes
Other Study ID Numbers: R01-DK59500
Study First Received: August 18, 2008
Last Updated: August 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013