UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028351 |
|---|---|
| Receipt number | 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 | 2024/01/28 12:46:08 |
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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
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
orl@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 16 | Day |
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
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031687
