In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00737802|
Recruitment Status : Recruiting
First Posted : August 20, 2008
Last Update Posted : September 21, 2017
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 or disease|
|GERD Barretts Esophagus|
The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.
The study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors' better treat future patients with reflux problems.
We plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett's esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD
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 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.
- Pressure at the gastric sling and clasp fibers [ Time Frame: 5 years ]esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737802
|Contact: Larry S Miller, M.D.||firstname.lastname@example.org|
|United States, New York|
|LIJ Medical Center- NSLIJ Health System||Recruiting|
|New Hyde Park, New York, United States, 11040|
|Contact: Larry Miller, M.D. 718-470-4691 email@example.com|
|Principal Investigator: Larry Miller, M.D.|
|Principal Investigator:||Larry S Miller, MD||Feinstein Institute for Medical Research|