Gastroesophageal Reflux Clinical Trial
Official title:
A Novel Disposable Transnasal Esophagoscope: a Prospective Pilot Trial of Feasibility, Safety and Tolerance
Verified date | February 2012 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
Study type | Observational |
This is a pilot study of a novel disposable transnasal esophagoscope for feasibility, safety and tolerance.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: 1. aged 20 years or older 2. 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 3. a written informed consent form Exclusion Criteria: 1. history or symptoms of severe rhinitis and sinusitis 2. symptoms of acute respiratory inflammation at the time of examination 3. abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous nasopharyngeal surgery 4. taking anticoagulants such as coumadin 5. patients for whom a EGD could not be performed |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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