UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019335 |
|---|---|
| Receipt number | R000022359 |
| Scientific Title | Examination of the effect and safety of office-based flexible endoscopic surgery for laryngeal papilloma using a carbon dioxide laser fiber |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2017/03/17 17:39:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effect and safety of office-based flexible endoscopic surgery for laryngeal papilloma using a carbon dioxide laser fiber
Acronym
Office-based flexible endoscopic surgery using a carbon dioxide laser fiber
Scientific Title
Examination of the effect and safety of office-based flexible endoscopic surgery for laryngeal papilloma using a carbon dioxide laser fiber
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yukio Katori |
Organization
Tohoku University School of Medicine
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7304
entsendai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Watanabe |
Organization
Tohoku University School of Medicine
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7304
Homepage URL
kenw@orl.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 08 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022359
