UMIN-CTR Clinical Trial

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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