UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect and safety of office-based flexible endoscopic surgery for laryngeal papilloma using a carbon dioxide laser fiber
Title of the study (Brief title)	Office-based flexible endoscopic surgery using a carbon dioxide laser fiber
Region	Japan

Condition
Condition	recurrent laryngeal papilloma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the safety and efficacy of surgical procedure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease resolution quantified by comparing pretreatment examinations at presentation to posttreatment evaluations 8 weeks after treatment
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	flexible endoscopic surgery using carbon dioxide laser
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) laryngeal papilloma 2) performance status 0 or 1 3) age more than 20 y.o. 4) surgical indication under general anesthesia
Key exclusion criteria	1) bronchial athma 2) allegies to lidocaine 3) during pregnancy 4) age more than 80 y.o. 5) heart, liver, kidney dysfunction
Target sample size	15

Research contact person
Name of lead principal investigator	Yukio Katori
Organization	Tohoku University School of Medicine
Division name	Otorhinolaryngology, Head and Neck Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7304
Email	entsendai@yahoo.co.jp

Public contact
Name of contact person	Kenichi Watanabe
Organization	Tohoku University School of Medicine
Division name	Otorhinolaryngology, Head and Neck Surgery
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7304
Homepage URL
Email	kenw@orl.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	donation
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 08 Day
Anticipated trial start date	2015 Year 10 Month 20 Day
Last follow-up date	2017 Year 02 Month 09 Day
Date of closure to data entry	2017 Year 02 Month 09 Day
Date trial data considered complete	2017 Year 02 Month 09 Day
Date analysis concluded	2017 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 13 Day
Last modified on	2017 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022359