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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017698
Receipt No. R000020422
Scientific Title CO2 laser therapy for laryngeal and tracheal lesion by the endoscope with the forceps channel
Date of disclosure of the study information 2015/06/01
Last modified on 2017/05/31

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Basic information
Public title CO2 laser therapy for laryngeal and tracheal lesion by the endoscope with the forceps channel
Acronym CO2 laser therapy by the endoscope with the forceps channel
Scientific Title CO2 laser therapy for laryngeal and tracheal lesion by the endoscope with the forceps channel
Scientific Title:Acronym CO2 laser therapy by the endoscope with the forceps channel
Region
Japan

Condition
Condition A larynx and trachea and pharyngeal inflammatory disorder, neoplastic disease
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Treatment with the endoscopy with the forceps channel reduces physical angor for the patients given local anesthesia surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Treatment successful execution rate
Key secondary outcomes Evaluation of the pain by Visual analog scale

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 CO2 laser therapy using FiberLaseTM via the endoscope with the forceps channel made in Lumenis.
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The patients with the inflammatory and neoplastic disease in larynx and trachea and the pharynx
Key exclusion criteria The cases that enough faucial reflex loss can't be obtained by local anesthesia.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Omori
Organization Fukushima Medical University
Division name Department of Otolaryngology
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1321
Email omori@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Ikeda
Organization Fukushima Medical University
Division name Departmetnt of Otolaryngology
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1321
Homepage URL
Email masakazu@fmu.ac.jp

Sponsor
Institute Department of Otolaryngology, Fukushima Medical University
Institute
Department

Funding Source
Organization contribution for encouragement to study by Fujita public hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 福島県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 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
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 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
2015 Year 05 Month 27 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020422

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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