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

NCT00737802 | Terminated

• 1 other identifier: R01DK059500
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GERD; Barretts Esophagus

Keywords

GERD; Heartburn; Esophageal reflux; Barretts esophagus; Normal subjects

Outcome Measures

Primary Outcomes (1)

• Pressure at the gastric sling and clasp fibers

  esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers

  5 years

Study Arms (3)

Normal Control

Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD

GERD Patients

GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.

Barrett's patients

Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal control subjects without GERD and patients with GERD

You may qualify if:

• Symptomatic heartburn
• Regurgitation
• Chest pain or water brash

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

LIJ Medical Center- NSLIJ Health System

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Barrett Esophagus; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Precancerous Conditions; Neoplasms; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Larry S Miller, MD

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: April 12, 2013
• Primary Completion: April 9, 2015
• Study Completion: February 3, 2017
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)