UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013287
Receipt number 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 09:00:36

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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 or person

Institute

Juntendo university Faculty of Medicine

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

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

Value
https://center6.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