Assessment of Esophageal Motility With Transnasal Endoscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Myung-gui Choi, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01658865
First received: August 3, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.


Condition
Esophageal Motility Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Agreement of endoscopic diagnosis of esophageal motor function with manometry [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns [ Time Frame: one day ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with esophageal motility disorder Healthy volunteer

Criteria

Inclusion Criteria:

  • 1) Healthy volunteer without organic esophageal or gastric disorder 2) Patients knwon esophageal motility disorder (such as achalasia)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658865

Contacts
Contact: Myung-Gyu Choi, Prof. 82-2-2258-2044 choim@catholic.ac.kr

Locations
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Myung-Gyu Choi, Prof    82-2-2258-2044    choim@catholic.ac.kr   
Sponsors and Collaborators
The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Myung-gui Choi, prof., The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01658865     History of Changes
Other Study ID Numbers: NE-EM-001
Study First Received: August 3, 2012
Last Updated: August 3, 2012
Health Authority: Republic of Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014