Esophageal Motility DisorderNCT01658865
Assessment of Esophageal Motility With Transnasal Endoscopy
An observational study of Esophageal Motility Disorder, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Motility Disorder
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Oct 2012
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with esophageal motility disorder Healthy volunteer
Who may be able to join
- 1) Healthy volunteer without organic esophageal or gastric disorder 2) Patients knwon esophageal motility disorder (such as achalasia)
Who cannot join
- severe organic esophageal disorder including severe reflux esophagitis, stricture, and bleeding.
- previous opertion of esophagus or stomach
- GI bleeding, mechanical obstruction
- medication which can infulence GI motility
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul
Myung-Gyu Choi, Prof, 82-2-2258-2044, choim@catholic.ac.kr
About this study
The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.
Read the detailed description
Esophageal manometry is a gold standard for diagnosis of esophageal motility disorder. However, esophageal manometry can not detect non-occulsive contraction. Endoscopic evaulation of esophageal motility is difficult becausea swallowing is nearly impossible during endoscopy. Simplified trans nasal endoscopy (E.G. ScanTM, IntroMedic Co.,Ltd.)composed with dysplay system,controller,and disposable probe with compact size.
The esophageal motor function will be assessed with both esophageal manometry and simplifed trnasnasal endoscopy in patients with esophageal motility disorder (such as achalasia) and healthy volunteer. The results of simplifed trnasnasal endoscopy is compared with the results of esophageal manometry.
- Conditions
- Esophageal Motility Disorder
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transnasal endoscopy | Healthy volunteers and patients with esophageal motor symptom will be enrolled and esophageal motility assessed by transnasal endoscopy according to clinical and manometric diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of endoscopic diagnosis of esophageal motor function with manometry
Measured: one day
Secondary outcomes (1)
Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Motility DisorderStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-gui Choi, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658865
- Sponsor's protocol ID
- NE-EM-001
- Status last verified
- Aug 2012
- First submitted
- 3 Aug 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Motility With Transnasal Endoscopy
- ClinicalTrials.gov ID
- NCT01658865
- Acronym / sponsor ID
- NE-EM-001
- Conditions
- Esophageal Motility Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 Aug 2012 (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.
The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.
Detailed description
Esophageal manometry is a gold standard for diagnosis of esophageal motility disorder. However, esophageal manometry can not detect non-occulsive contraction. Endoscopic evaulation of esophageal motility is difficult becausea swallowing is nearly impossible during endoscopy. Simplified trans nasal endoscopy (E.G. ScanTM, IntroMedic Co.,Ltd.)composed with dysplay system,controller,and disposable probe with compact size.
The esophageal motor function will be assessed with both esophageal manometry and simplifed trnasnasal endoscopy in patients with esophageal motility disorder (such as achalasia) and healthy volunteer. The results of simplifed trnasnasal endoscopy is compared with the results of esophageal manometry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transnasal endoscopy | – | –Healthy volunteers and patients with esophageal motor symptom will be enrolled and esophageal motility assessed by transnasal endoscopy according to clinical and manometric diagnosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal motility disorder Healthy volunteer
Key inclusion criteria (1 listed)
- 1) Healthy volunteer without organic esophageal or gastric disorder 2) Patients knwon esophageal motility disorder (such as achalasia)
Key exclusion criteria (4 listed)
- severe organic esophageal disorder including severe reflux esophagitis, stricture, and bleeding.
- previous opertion of esophagus or stomach
- GI bleeding, mechanical obstruction
- medication which can infulence GI motility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement of endoscopic diagnosis of esophageal motor function with manometry
Time frame: one day
1 secondary outcome
Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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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.
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 Esophageal Motility Disorder, run by The Catholic University of Korea at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 7 Aug 2012. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Gyu Choi, Prof. (82-2-2258-2044, choim@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of endoscopic diagnosis of esophageal motor function with manometry (time frame: one day). 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 7 Aug 2012.