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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028351
Receipt No. R000031687
Scientific Title Clinical research on an off-label use of implant-type tissue-engineered cartilage
Date of disclosure of the study information 2017/07/24
Last modified on 2017/07/24

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Basic information
Public title Clinical research on an off-label use of implant-type tissue-engineered cartilage
Acronym Off-label use of tissue-engineered cartilage
Scientific Title Clinical research on an off-label use of implant-type tissue-engineered cartilage
Scientific Title:Acronym Off-label use of tissue-engineered cartilage
Region
Japan

Condition
Condition Cholesteatoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of the off-label use of implant-type tissue-engineered cartilage for reconstruction of external auditory canal in otologic surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Retraction of external auditory canal evaluated by CT at 6-months after surgery, compared to the state at 3-months after surgery.
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
Other
Interventions/Control_1 Use of implant-type tissue-engineered cartilage for reconstruction of external auditory canal in otologic 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
70 years-old >
Gender Male and Female
Key inclusion criteria Cholesteatoma with indication for surgery (moderate or severe case)
Key exclusion criteria 1. Post-operative ear
2. infection with MRSA, Pseudomonas with multiple drug resistances, etc.
3. Continuous purulent discharge (otorrhea)
4. When anticoagulant drugs cannot be discontinued
5. Diabetes mellitus with poor control
6. Severe disorder in circulatory, respiratory, hepatic, renal, or hematologic organs
7. Severe allergic disease
8. inability to use post-operative antibiotics because of drug allergy
9. Malignant disease in internal organs, blood, etc.
10. Addict of narcotic drugs, alcohol, etc.
etc.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken ITO
Organization Teikyo University Hospital
Division name Otolaryngology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, JAPAN
TEL 03-3964-1211
Email itoken-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken ITO
Organization Teikyo University Hospital
Division name Otolaryngology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, JAPAN
TEL 03-3964-1211
Homepage URL
Email orl@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo 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
2017 Year 07 Month 24 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 24 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
2017 Year 07 Month 24 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031687

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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