Expired Study
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Louisville, Kentucky 40202


Purpose:

High Resolution Manometry is a new technology that utilizes 36 solid state sensors on a thin catheter spaced at 1-cm intervals. One can more effectively measure the pressure of the esophagus. It includes a sophisticated software to display the pressures data as color topography plot using time, length of the esophagus and pressure within the entire esophagus. It is unclear if this technology improvement actually correlates with patient's symptoms.


Study summary:

In a 2007 retrospective study performed using this technology, 400 subjects referred to the motility lab underwent high resolution manometry (HRM) for complaints of dysphasia, gastroesophageal reflux disease, chest pain and miscellaneous complaints. HRM offered greater detail of individual contracting segments of the esophagus, including the duration of contraction and propagation of individual contractions. For example, a new subclass of achalasia was defined by HRM. In this classification, achalasia is divided into types 1, 2 and 3. Type 1 corresponds to classic achalasia (complete esophageal motor failure), type 2 is a compression achalasia (simultaneous panesophageal pressurization with aperistalsis), and type 3 is spastic achalasia with aperistalsis (100% spasm). However, it is unclear if this categorization represents a spectrum of disease among patients with achalasia, or it represents distinct subgroups of patients with different symptom presentation and etiology. This study will attempt to correlate the data from HRM to patient's chief compliants, symptom severity, and clinical presentation.


Criteria:

Inclusion Criteria: - Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications. Exclusion Criteria: - Pregnancy - Unable to give consent - Less than 18 years old - Prisoner


Study is Available At:


Original ID:

10.0057


NCT ID:

NCT01202929


Secondary ID:


Study Acronym:


Brief Title:

Correlation of High Resolution Esophageal Manometry With Symptoms


Official Title:

Correlation of High Resolution Esophageal Manometry With Symptoms


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Louisville


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Principal investigator has left the Institut


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:John Wo, MD
Principal Investigator
University of Louisville School of Medicine

Study Dates

Start Date:February 2010
Completion Date:March 2013
Completion Type:Anticipated
Primary Completion Date:February 2013
Primary Completion Type:Anticipated
Verification Date:August 2011
Last Changed Date:August 4, 2011
First Received Date:September 14, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Differences and similarities in patients with achalasia
Time Frame:at 24 months
Safety Issues:False
Description:To determine the differences and similarities in the clinical presentation of patients with type 1, 2 and 3 achalasia based on the Chicago classification for HRM
Outcome Type:Secondary Outcome
Measure:Esophageal dysmotility in patients with dysphagia and GERD symptoms
Time Frame:at 24 months
Safety Issues:False
Description:To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.
Outcome Type:Secondary Outcome
Measure:HRM parameters
Time Frame:at 24 months
Safety Issues:False
Description:To determine if HRM parameters reflect esophageal physiology between contractile strength of the esophagus and GEJ residual pressure obstructing esophageal flow.
Outcome Type:Secondary Outcome
Measure:Esophageal dysmotility in patients with postfundoplication compliants
Time Frame:at 24 months
Safety Issues:False
Description:To determine the prevalence of esophageal dysmotility using the Chicago classification based in patients with postfundoplication complaints.
Outcome Type:Secondary Outcome
Measure:Correlation between HRM and symptoms
Time Frame:At 24 months
Safety Issues:False
Description:To determine if HRM parameters reflect symptom presentations.

Study Interventions

Intervention Type:Procedure
Name:High Resolution Manometry
Description:High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.
Arm Name:Type I achalasia
Other Name:Manometry

Study Arms

Study Arm Type:Other
Arm Name:Type I achalasia
Description:classic achalasia: complete esophageal motor failure
Study Arm Type:Other
Arm Name:Type II achalasia
Description:compression achalasia: simultaneous panesophageal pressurization with aperistalsis
Study Arm Type:Other
Arm Name:Type III achalasia
Description:spastic achalasia with aperistalsis: 100% spasm

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Louisville

Samples and Retentions

Study Population: Subjects will be recruited from patients referred to the University Medical Associates motility lab for high resolution manometry
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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