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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033251
Receipt No. R000037861
Official scientific title of the study Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/02

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Basic information
Official scientific title of the study Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Title of the study (Brief title) Evaluation of the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods
Region
Japan

Condition
Condition pharyngolaryngeal epithelial tumor, epithelial tumor of digestive tract, inflammatory bowel disease
Classification by specialty
Gastroenterology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to evaluate the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic agreement between diagnosis by endocytoscopy and pathological diagnosis by biopsy, endoscopic resection and operation.
Key secondary outcomes Diagnostic ability for tumor and inflammatory bowel disease by endocytoscopy (sensitivity, specificity, positive predictive value, and negative predictive value), Diagnostic ability of depth of invasion of tumor (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value)

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo an endoscopy with endocytoscopy
Key exclusion criteria Patients who did not obtain consent
Target sample size 130

Research contact person
Name of lead principal investigator Takeshi Yamamura
Organization Nagoya university hospital
Division name Department of Endoscopy
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL 0527412172
Email tyamamu@med.nagoya-u.ac.jp

Public contact
Name of contact person Masaya Esaki
Organization Nagoya university hospital
Division name Department of Endoscopy
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
TEL 0527412172
Homepage URL
Email em6089@med.nagoya-u.ac.jp

Sponsor
Institute Department of Endoscopy, Nagoya university hospital
Institute
Department

Funding Source
Organization Department of Endoscopy, Nagoya university hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 07 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 10 Day
Anticipated trial start date
2018 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This study is to evaluate the usefulness and safety of Endo-Cytoscopy-System using in vivo staining methods

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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