AchalasiaNCT01202929
Correlation of High Resolution Esophageal Manometry With Symptoms
An observational study of Achalasia and Dysphagia, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- High Resolution Manometry
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from patients referred to the University Medical Associates motility lab for high resolution manometry
Who may be able to join
- Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications.
Who cannot join
- Pregnancy
- Unable to give consent
- Less than 18 years old
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
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.
Read the detailed description
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.
- Conditions
- Achalasia, Dysphagia, GERD, Chest Pain, Post Fundoplication
- Being tested
- High Resolution Manometry
- Keywords
- High Resolution Manometry, achalasia, dysphagia, GERD, chest pain, Post fundoplication
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders, Gastroesophageal Reflux, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution ManometryProcedure or surgery
Also called Manometry, Achalasia
High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Type I achalasia | classic achalasia: complete esophageal motor failure Receives: Procedure: High Resolution Manometry | |
| Type II achalasia | compression achalasia: simultaneous panesophageal pressurization with aperistalsis Receives: Procedure: High Resolution Manometry | |
| Type III achalasia | spastic achalasia with aperistalsis: 100% spasm Receives: Procedure: High Resolution Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 24 months
Secondary outcomes (4)
Esophageal dysmotility in patients with dysphagia and GERD symptoms
To determine the prevalence of esophageal dysmotility using the Chicago classification based on primary chief complaints.
Measured: at 24 months
HRM parameters
To determine if HRM parameters reflect esophageal physiology between contractile strength of the esophagus and GEJ residual pressure obstructing esophageal flow.
Measured: at 24 months
Esophageal dysmotility in patients with postfundoplication compliants
To determine the prevalence of esophageal dysmotility using the Chicago classification based in patients with postfundoplication complaints.
Measured: at 24 months
Correlation between HRM and symptoms
To determine if HRM parameters reflect symptom presentations.
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Principal investigator has left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Wo, MD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202929
- Sponsor's protocol ID
- 10.0057
- Status last verified
- Apr 2017
- First submitted
- 14 Sep 2010
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of High Resolution Esophageal Manometry With Symptoms
- ClinicalTrials.gov ID
- NCT01202929
- Acronym / sponsor ID
- 10.0057
- Conditions
- Achalasia, Dysphagia, GERD, Chest Pain, Post Fundoplication
- Keywords
- High Resolution Manometry, achalasia, dysphagia, GERD, chest pain, Post fundoplication
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal investigator has left the Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type I achalasia | – | Procedure: High Resolution Manometryclassic achalasia: complete esophageal motor failure |
| Type II achalasia | – | Procedure: High Resolution Manometrycompression achalasia: simultaneous panesophageal pressurization with aperistalsis |
| Type III achalasia | – | Procedure: High Resolution Manometryspastic achalasia with aperistalsis: 100% spasm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from patients referred to the University Medical Associates motility lab for high resolution manometry
Key inclusion criteria (1 listed)
- Subjects who are referred to the motility lab to undergoing esophageal HRM for various clinical indications.
Key exclusion criteria (4 listed)
- Pregnancy
- Unable to give consent
- Less than 18 years old
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Resolution ManometryAlso: Manometry, AchalasiaHigh Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach. | Procedure or surgery | Type I achalasia, Type II achalasia, Type III achalasia |
Primary outcome
Differences and similarities in patients with achalasia
Time frame: at 24 months
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
4 secondary outcomes
Esophageal dysmotility in patients with dysphagia and GERD symptoms
Time frame: at 24 months
HRM parameters
Time frame: at 24 months
Esophageal dysmotility in patients with postfundoplication compliants
Time frame: at 24 months
Correlation between HRM and symptoms
Time frame: At 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Wo, MD principal investigator
University of Louisville School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Dysphagia, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences and similarities in patients with achalasia (time frame: at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.