UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000036518 |
| Receipt No. | R000041605 |
| Scientific Title | end-to-side nerve graft for facial nerve reconstruction |
| Date of disclosure of the study information | 2019/04/16 |
| Last modified on | 2019/04/15 (Ver. 1) |
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| Basic information | ||
| Public title | end-to-side nerve graft for facial nerve reconstruction | |
| Acronym | end-to-side nerve graft for facial nerve reconstruction | |
| Scientific Title | end-to-side nerve graft for facial nerve reconstruction | |
| Scientific Title:Acronym | end-to-side nerve graft for facial nerve reconstruction | |
| Region |
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| Condition | ||
| Condition | facial nerve defect | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | to evaluate the efficacy of ten end-to-side nerve graft for facial nerve reconstruction |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Yanagihara score, House-Blackmann score |
| 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 | Self control |
| 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 | end-to-side "loop" graft for facial nerve reconstruction | |
| 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 | patients with more than 18 months follo-up | |||
| Key exclusion criteria | other than above | |||
| Target sample size | 32 | |||
| Research contact person | |||||||
| Last name of lead principal investigator |
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| Organization | Niigata University | ||||||
| Division name | Graduate School of Medicine | ||||||
| Zip code | 951-8510 | ||||||
| Address | 1-757, Asahimachi 1 Niigata Chuo-ku | ||||||
| TEL | 0252272592 | ||||||
| matsuken@med.niigata-u.ac.jp | |||||||
| Public contact | |||||||
| 1st name of contact person |
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| Organization | Niigata University | ||||||
| Division name | Graduate School of Medicine | ||||||
| Zip code | 951-8510 | ||||||
| Address | 1-757, Asahimachi 1 Niigata Chuo-ku | ||||||
| TEL | 0252272592 | ||||||
| Homepage URL | |||||||
| matsuken@med.niigata-u.ac.jp | |||||||
| Sponsor | |
| Institute | Niigata University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Niigata University |
| Organization | |
| Division | |
| Category of Funding Organization | Japanese Governmental office |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Niigata University |
| Address | Niigata University |
| Tel | 0252272592 |
| matsuken@med.niigata-u.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 | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | http://dx.doi.org/10.1016/j.bjps.2015.04.005 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | http://dx.doi.org/10.1016/j.bjps.2015.04.005 | ||||||
| Number of participants that the trial has enrolled | 32 | ||||||
| Results | http://dx.doi.org/10.1016/j.bjps.2015.04.005 |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results |
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| Baseline Characteristics | patients with facial nerve reconstruction using end-to-side nerve graft |
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| Participant flow | postoperative follow-up in outpatient clinics |
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| Adverse events | none |
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| Outcome measures | Yanagihara score House-Blackmann scale |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| 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=R000041605 |
