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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032968
Receipt No. R000036962
Official scientific title of the study A Study on the Usefulness of Nerve Conduit with Autologous Nerve in Cross Link Nerve Transplantation for Facial Nerve Paralysis.
Date of disclosure of the study information 2018/06/13
Last modified on 2018/06/13

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Basic information
Official scientific title of the study A Study on the Usefulness of Nerve Conduit with Autologous Nerve in Cross Link Nerve Transplantation for Facial Nerve Paralysis.
Title of the study (Brief title) A study on the usefulness of nerve conduit with autologous nerve added for facial nerve paralysis.
Region
Japan

Condition
Condition Facial paralysis
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose of investigating the usefulness of nerve conduit with autologous nerve added for facial nerve paralysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Recipient site
Improvement of symptoms caused by facial nerve paralysis is evaluated by facial nerve paralysis score (Sunnybrook score).

Key secondary outcomes ・Donor site
2 point discrimination(2PD) and Semmes-Weinstein Monofilament test of sural nerve dominant region.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Surgery
Follow-up period: 2 years
Number of times: 1 time
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
16 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria After months or more since the onset of facial nerve palsy, patients who are suffering from paralysis and whose symptoms such as muscle weakness, contracture of the muscles, pathological synergy, and convulsions are fixed, and remain as sequelae are included.
Patients with complete paralysis who are not more than two years old since onset and whose facial muscular atrophy is not advanced are included.
Key exclusion criteria Patients with facial nerve complete paralysis that showed advanced atrophy and contracture of facial muscles with no improvement after more than two years since onset.
Target sample size 24

Research contact person
Name of lead principal investigator Ryosuke Tamura
Organization Kobe university hospital
Division name Plastic surgery
Address 2-5-7, Kusunokicho, Tyuuouku, Kobe city, Hyogo
TEL 078-382-6251
Email tamryo8041@gmail.com

Public contact
Name of contact person Ryosuke Tamura
Organization Kobe university hospital
Division name Plastic surgery
Address 2-5-7, Kusunokicho, Tyuuouku, Kobe city, Hyogo
TEL 078-382-6251
Homepage URL
Email tamryo8041@gmail.com

Sponsor
Institute Kobe university hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 06 Month 13 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 13 Day
Anticipated trial start date
2018 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036962

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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