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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037578
Receipt No. R000042841
Scientific Title Research on the use evaluation of the operator about the opening device for infants at the newly developed adenoid resection and palatine tonsillectomy
Date of disclosure of the study information 2019/08/02
Last modified on 2020/02/01

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Basic information
Public title Research on the use evaluation of the operator about the opening device for infants at the newly developed adenoid resection and palatine tonsillectomy
Acronym Research on the use evaluation of the operator about the opening device for infants at the newly developed adenoid resection and palatine tonsillectomy
Scientific Title Research on the use evaluation of the operator about the opening device for infants at the newly developed adenoid resection and palatine tonsillectomy
Scientific Title:Acronym Evaluation of use of infant opening device
Region
Japan

Condition
Condition Adenoid hypertrophy / palatine tonsilla hypertrophy
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of use of newly developed infant opening device at the time of surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ease of setting the opening, holding / opening state / stability, size of the operation field, judgment of ease of procedure by the operator
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 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 Evaluation of a Newly Developed Adenoidectomy and Otolaryngologist performing surgery on use of the infant opening device during palatine tonsillectomy (at the time of adenoid resection and palatine tonsillectomy in the operation subject described in eligibility)
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
3 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Indications for adenoidectomy and palatine tonsillectomy
Key exclusion criteria not in particular
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takemi
Middle name
Last name Otsuki
Organization Kawasaki Medical School
Division name Department of Hygiene
Zip code 701-0192
Address 577 Matsushima, Kurashiki
TEL 0864621111
Email takemi@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Takemi
Middle name Otsuki
Last name Otsuki
Organization Kawasaki Medical School
Division name Department of Hygiene
Zip code 701-0192
Address 577 Matsushima, Kurashiki
TEL 0864621111
Homepage URL
Email takemi@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 Kawasaki Medical School and Hospitai Ethics Committee
Address 577 Matsushima
Tel 0864621111
Email takemi@med.kawasaki-m.ac.jp

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 川崎医科大学、川崎医科大学附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 02 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
2019 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 08 Month 02 Day
Last modified on
2020 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042841

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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