NCT01360515

Brief Summary

This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

May 23, 2011

Last Update Submit

February 1, 2012

Conditions

Gastroesophageal RefluxEsophageal VaricesEsophageal Disease

Keywords

esophagoscopeesophageal diseasegastroesophageal refluxesophageal varices

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50

You may qualify if:

  • aged 20 years or older
  • endoscopy indicated for reflux symptoms (heartburn, epigastric soreness and/or regurgitation), dyspepsia (epigastric discomfort, bloating, early satiety), or non-cardiogenic chest pain, or known or suspected to have esophageal varices, infectious esophagitis, or other esophageal disease based on their medical history
  • a written informed consent form

You may not qualify if:

  • history or symptoms of severe rhinitis and sinusitis
  • symptoms of acute respiratory inflammation at the time of examination
  • abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous nasopharyngeal surgery
  • taking anticoagulants such as coumadin
  • patients for whom a EGD could not be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal RefluxEsophageal and Gastric VaricesEsophageal Diseases

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Si Young Song, M.D., Ph.D.

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

KR(1)