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Coordination Versus Pressure in Oesophageal Peristalsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482885
First Posted: June 5, 2007
Last Update Posted: June 27, 2011
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. Read our disclaimer for details.
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
  Purpose

High Resolution Manometry (HRM) is a new advance in oesophageal measurement that permits the acquisition of pressure data through the entire length of the oesophagus over time via closely spaced sensors that continuously record the motor activity of the oesophagus. This allows not only contractile pressure to be measured, but also the coordination (proximal-distal) of contractions and the development of effective intra-bolus pressure (the force that drives bolus movement).

The study hypothesis is that (1) there will be a progressive increase in peristaltic pressure and decrease in velocity as the subjects move from the upright, through the supine to the upside down position and (2) the increase in pressure will be most evident in the mid-oesophagus at the transition zone between the striated and the smooth muscle contractions.


Condition
Gastroesophageal Reflux

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Position on Oesophageal Peristalsis and LOS Pressures: a High Resolution Manometry Study

Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Enrollment: 25
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy controls and patients presenting with symptoms of reflux and endoscopy negative dysphagia
Criteria

Inclusion criteria

Subjects to be included in the study are those:

  1. male or female
  2. at least 18 years of age
  3. have given informed consent for the HRM procedure

Exclusion Criteria

For normal controls:

  1. with symptoms or a history of oesophageal gastrointestinal disease
  2. with regular intake of medication. Occasional use of analgesic (e.g. aspirin) is allowed
  3. with any hematological abnormalities
  4. with any evidence of infectious disease
  5. who are pregnant or breast-feeding.
  6. with evidence or history of drug or alcohol abuse within the past two years
  7. with diabetes mellitis
  8. with mental impairment limiting the ability to comply with study requirements
  9. who are taking or planning to take other investigational drugs during the study
  10. with use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics).
  11. with use of PPIs and H2 blockers

For patients:

  1. with no oesophageal symptoms (e.g. referred for studies prior to bariatric surgery)
  2. with mental impairment limiting the ability to comply with study requirements
  3. who are taking or planning to take other investigational drugs during the study
  4. with use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics).
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00482885


Locations
United Kingdom
Oesophageal Laboratory, GSTT
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Mark Fox, MD Honorary Consultant and Senior Lecturer
  More Information

Responsible Party: Dr Rami Sweis, St Thomas' Hospital
ClinicalTrials.gov Identifier: NCT00482885     History of Changes
Other Study ID Numbers: 07/Q0702/3
First Submitted: June 1, 2007
First Posted: June 5, 2007
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Esophagus
Peristalsis
Contractile Pressure
Coordination of contraction
Bolus transport
Esophageal function

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