UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017698 |
|---|---|
| Receipt number | 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 13:10:22 |
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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
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
masakazu@fmu.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
