Correlation of High Resolution Esophageal Manometry With Symptoms

NCT01202929 | Withdrawn

• 1 other identifier: 10.0057
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achalasia; Dysphagia; GERD; Chest Pain; Post Fundoplication

Keywords

High Resolution Manometry; achalasia; dysphagia; GERD; chest pain; Post fundoplication

Outcome Measures

Primary Outcomes (1)

• Differences and similarities in patients with achalasia

  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

  at 24 months

Secondary Outcomes (4)

• Esophageal dysmotility in patients with dysphagia and GERD symptoms

  at 24 months

• HRM parameters

  at 24 months

• Esophageal dysmotility in patients with postfundoplication compliants

  at 24 months

• Correlation between HRM and symptoms

  At 24 months

Study Arms (3)

Type I achalasia

classic achalasia: complete esophageal motor failure

Procedure: High Resolution Manometry

Type II achalasia

compression achalasia: simultaneous panesophageal pressurization with aperistalsis

Procedure: High Resolution Manometry

Type III achalasia

spastic achalasia with aperistalsis: 100% spasm

Procedure: High Resolution Manometry

Interventions

High Resolution Manometry PROCEDURE

High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.

Also known as: Manometry, Achalasia

Type I achalasia; Type II achalasia; Type III achalasia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from patients referred to the University Medical Associates motility lab for high resolution manometry

You may qualify if:

• Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications.

You may not qualify if:

• Pregnancy
• Unable to give consent
• Less than 18 years old
• Prisoner

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia; Deglutition Disorders; Gastroesophageal Reflux; Chest Pain

Interventions

Manometry

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• John Wo, MD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)