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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013287
Receipt No. R000015495
Scientific Title Measurement of micro displacement of eyeball using PVDF film during endoscopic sinus surgery
Date of disclosure of the study information 2014/02/26
Last modified on 2018/03/09

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Basic information
Public title Measurement of micro displacement of eyeball using PVDF film during endoscopic sinus surgery
Acronym Measurement of eyeball vibration using PVDF film during ESS
Scientific Title Measurement of micro displacement of eyeball using PVDF film during endoscopic sinus surgery
Scientific Title:Acronym Measurement of eyeball vibration using PVDF film during ESS
Region
Japan

Condition
Condition sinusitis and sinonasal bening tumor
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 make the warning device which prevents endoscopic surgical accidents using measurement of eyeball motion by PVDF
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of eyeball vibration during endoscopic sinus surgery using PVDF film
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 measurement of eyeball displacement using PVDF film
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1, sinonasal benign desease with endoscopic ethmoidal sinus surgery underwent general esthesia
2,patient who were provided written informed consent
Key exclusion criteria 1, sinonasal malignancy
2, lack of agreement
3, Those who are determined as not appropriate for the study by doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Ito
Organization Juntendo university Faculty of Medicine
Division name Departement of Otorhinolaryngology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 0358021229
Email shin709@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Ito
Organization Juntendo university Faculty of Medicine
Division name Departement of Otorhinolaryngology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 0358021229
Homepage URL
Email shin709@juntendo.ac.jp

Sponsor
Institute Juntendo university Faculty of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2014 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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

Management information
Registered date
2014 Year 02 Month 26 Day
Last modified on
2018 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015495

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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