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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01658865
Other study ID # NE-EM-001
Secondary ID
Status Unknown status
Phase N/A
First received August 3, 2012
Last updated August 3, 2012
Start date July 2011
Est. completion date October 2012

Study information

Verified date August 2012
Source The Catholic University of Korea
Contact Myung-Gyu Choi, Prof.
Phone 82-2-2258-2044
Email choim@catholic.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 40
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Locations

Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Agreement of endoscopic diagnosis of esophageal motor function with manometry one day
Secondary Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns one day