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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Cholesteatoma | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 3 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |