UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008107 |
|---|---|
| Receipt number | R000009501 |
| Scientific Title | Observational study for the capability of pharyngeal examination using upper gastrointestinal endoscopy |
| Date of disclosure of the study information | 2012/06/10 |
| Last modified on | 2013/11/29 13:27:57 |
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Basic information
Public title
Observational study for the capability of pharyngeal examination using upper gastrointestinal endoscopy
Acronym
Observational study for the capability of pharyngeal examination using upper gastrointestinal endoscopy
Scientific Title
Observational study for the capability of pharyngeal examination using upper gastrointestinal endoscopy
Scientific Title:Acronym
Observational study for the capability of pharyngeal examination using upper gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the capability of pharyngeal examination using upper gastrointestinal endoscopy
Basic objectives2
Others
Basic objectives -Others
To evaluate the capability of pharyngeal observation using upper gastrointestinal endoscopy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of recorded still images among the specified pharyngeal regions
Key secondary outcomes
The time required for pharyngeal examination
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or above,
Patients who agree to participate in the study by written informed consent
Key exclusion criteria
Patients with history of pharyngectomy or laryngectomy,
Patients with history of pharyngeal endoscopic resection,
Patients who have some pharyngeal lesion that need further evaluation,
Patients with mental disorder or psychiatric symptom
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Doyama |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL
076-237-8211
doyama.134@ipch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Yoshida |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL
076-237-8211
Homepage URL
naohilow@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2012 | Year | 06 | Month | 05 | Day |
Last modified on
| 2013 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
