UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CO2 laser therapy for laryngeal and tracheal lesion by the endoscope with the forceps channel
Title of the study (Brief title)	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	Koichi Omori
Organization	Fukushima Medical University
Division name	Department of Otolaryngology
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1321
Email	omori@fmu.ac.jp

Public contact
Name of contact person	Masakazu Ikeda
Organization	Fukushima Medical University
Division name	Departmetnt of Otolaryngology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020422