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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035968
Receipt No. R000040968
Scientific Title Clinical effects of submucosal middle turbinectomy for eosinophilic chronic rhinosinusitis
Date of disclosure of the study information 2019/02/21
Last modified on 2019/02/21

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Basic information
Public title Clinical effects of submucosal middle turbinectomy for eosinophilic chronic rhinosinusitis
Acronym submucosal middle turbinectomy
Scientific Title Clinical effects of submucosal middle turbinectomy for eosinophilic chronic rhinosinusitis
Scientific Title:Acronym submucosal middle turbinectomy
Region
Japan

Condition
Condition Eosinophilic chronic rhinosisusitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of submucoal middle turbinectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical effects of SMT.
Key secondary outcomes Long term effects of SMT

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
Maneuver
Interventions/Control_1 SMT is performed to ECRS patient durling endoscopic sinus surgery.
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

Not applicable
Gender Male and Female
Key inclusion criteria Adult ECRS patients who recieve endoscopic sinus surgery.
Key exclusion criteria Under 20 years old
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosuke Akiyama
Organization Faculty of Medicine, Kagawa University
Division name Department of Otolaryngology
Zip code
Address Kita-gun, Miki-cho, Ikenobe 1750-1, Kagawa 761-0793, Japan
TEL 087-891-2214
Email kakaka@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Akiyama
Organization Faculty of Medicine, Kagawa University
Division name Department of Otolaryngology
Zip code
Address +81-087-891-2214
TEL 087-891-2214
Homepage URL
Email kakaka@med.kagawa-u.ac.jp

Sponsor
Institute Faculty of Medicine, Kagawa University
Institute
Department

Funding Source
Organization Faculty of Medicine, Kagawa University
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2014 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 18 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
2019 Year 02 Month 21 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040968

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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