Assessment of Esophageal Motility With Transnasal Endoscopy | NCT01658865

Studies
Assessment of Esophageal Motility With Transnasal Endoscopy

NCT01658865

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Aug 7, 2012Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Esophageal Motility Disorder

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Sep 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Aug 3, 2012

First Submission Date that Met QC Criteria

Aug 3, 2012

First Posted Date

Aug 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2012

Last Update Posted Date

Aug 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Myung-gui Choi, prof., The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Agreement of endoscopic diagnosis of esophageal motor function with manometry		one day

Secondary Outcomes

Measure	Description	Time Frame
Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns		one day

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with esophageal motility disorder Healthy volunteer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Myung-Gyu Choi, Prof.	Contact	82-2-2258-2044		choim@catholic.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's Hospital	Recruiting	Seoul			South Korea

Type	Date	Date Unknown
Release	Jul 28, 2014
Reset	Aug 14, 2014
Release	Aug 24, 2014
Reset	Sep 3, 2014
Release	Sep 17, 2020
Reset	Oct 9, 2020

Submission Tracking

Estimated Results First Submitted Date

Jul 28, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 28, 2014			Aug 14, 2014
Aug 24, 2014

Condition Browse Module

MeSH Terms

ID	Term
D015154	Esophageal Motility Disorders

Ancestor Terms

ID	Term
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided