vMII for Measurement of Oesophageal Bolus Transport and Reflux

vMII for Measurement of Oesophageal Bolus Transport and Reflux
This study has been terminated.
( prototype catheter never delivered )

First Received on January 15, 2008.  
Last Updated on July 31, 2009  
History of Changes
Sponsor: Guy’s and St Thomas’ NHS Foundation Trust
Information provided by: Guy’s and St Thomas’ NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00604942

Recent work at St. Thomas’ has validated an innovative new design of a multichannel intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in healthy volunteers and patients. This project will establish the clinical value of volume sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same catheter (ROC analysis). Studies will assess:

  1. The accuracy of volume measurements and correlation between symptoms and the volume of bolus retention in patients with dysphagia.
  2. The accuracy of volume measurements and correlation between symptoms and reflux volume in patients with reflux disease.

Follow up studies after appropriate treatment will assess whether symptomatic improvement is associated with a reduction in oesophageal volume retention/reflux.

The vMII technique will be applied with high resolution manometry (HRM). These investigations are complementary in that vMII assesses the success or failure of bolus transport (or occurrence of reflux) and HRM can assess:

  1. the oesophageal dysfunction that results in bolus escape
  2. the abnormal events at the gastro−oesophageal junction (reflux barrier) that allow reflux to occur.

with a reduction in oesophageal volume retention / reflux.

Condition Intervention
Procedure: Heller’s Myotomy
Procedure: Nissen Fundoplication
Drug: domperidone or esomeprazole (Conservative management)
Drug: Esomeprazole 40 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Volume Sensitive Multichannel Intraluminal Impedance (vMII) for the Measurement of Oesophageal Bolus Transport and Reflux

Resource links provided by NLM:

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

Primary Outcome Measures:

  • Does vMII provide an accurate assessment of volume in disease? [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Does vMII assessment of volume improve the accuracy with which ‘events’ are associated with symp? [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Does symp improvement post treatment correlate with reduced ‘volume events’?. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: November 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)


Assigned Interventions
Experimental: Achalasia

Long vs Short Myotomy repair of Achalasia
Procedure: Heller’s Myotomy

Long vs Short Heller’s Myotomy for Achalasia
Experimental: Dysphagia control

Conservative Management
Drug: domperidone or esomeprazole (Conservative management)

Conservative management for dysphagia not referred for surgery. Conservative management: balloon dilatation or drugs such as domperidone 10 mg or esomeprazole 40 mg
Experimental: GORD for surgery

Partial vs Full Fundoplication repair
Procedure: Nissen Fundoplication

Partial vs Full Fundoplication for GORD
Experimental: GORD not for surgery

esomeprazole 40 mg vs no esomeprazole
Drug: Esomeprazole 40 mg

Esomeprazole vs no esomeprazole for GORD not referred for surgery

Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female
  • at least 18 years of age
  • have given informed consent for the vMII and Barium videofluoroscopy
  • have symptoms of reflux, dysphagia, have known achalasia or are planned for anti-reflux surgery

Exclusion Criteria:

  • with medications influencing gastrointestinal function within 3 days of the study
  • with those on anticoagulants
  • with any hematological abnormalities
  • with any evidence of infectious disease
  • who are pregnant or breast-feeding or sexually active and not on contraception.
  • with evidence or history of drug or alcohol abuse within the past two years
  • with diabetes mellitus
  • with severe physical or mental health concerns on screening which may contribute to the ability to comply with study requirements
  • with active co-morbid conditions
  • with oesophageal surgery or stent (dilation acceptable)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604942

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

No publications provided

Responsible Party: Dr Mark Fox, Guy’s and St Thomas’ NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00604942    
History of Changes
Other Study ID Numbers: 07/H0802/73
Study First Received: January 15, 2008
Last Updated: July 31, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Guy’s and St Thomas’ NHS Foundation Trust:

High Resolution Manometry
Contractile Pressure
Coordination of contraction
Bolus transport

Additional relevant MeSH terms:

Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2012

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