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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032336
Receipt No. R000035782
Scientific Title Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection for patients with head and neck cancer - A Prospective Multicenter Clinical Study
Date of disclosure of the study information 2018/04/20
Last modified on 2019/11/18

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Basic information
Public title Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection for patients with head and neck cancer - A Prospective Multicenter Clinical Study
Acronym Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection- A Prospective Multicenter Clinical Study
Scientific Title Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection for patients with head and neck cancer - A Prospective Multicenter Clinical Study
Scientific Title:Acronym Assessment of the efficacy and safety of accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection- A Prospective Multicenter Clinical Study
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 the efficacy of accessory nerve reconstruction using nerve regeneration inducing tube (Nerbridge, TOYOBO CO., LTD. JAPAN) in neck dissection for patients with head and neck cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the active range of shoulder abductive motion at postoperative after 24 months
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
Device,equipment
Interventions/Control_1 accessory nerve reconstruction using nerve regeneration inducing tube in neck dissection
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Head and Neck cancer(Lip and Oral Cavity, Nasal sinus, Nasopharynx, Oropharynx, Hypopharynx, Larynx, Salivary gland) proven histologically and scheduled to undergo unilateral neck dissection including Level II,III and IV.
2)Patients who can undergo rehabilitation and access the functions postoperatively.
3)ECOG PS 0-1 within 14 days before the registration
4)Adequate organ function.
5)Patients who can answer the survey questions .
6)Having provided voluntary written consent for participation in this study.
Key exclusion criteria 1)Patients who underwent the ipsilateral neck dissection or radiotherapy before.
2)Patients who registered other clinical trial (intervention study or Japanese registration trial) for head and neck cancer before.
3)Patients with infections requiring systematic treatment
4)Multiple malignancies except for carcinoma in situ and intramucosal cancer.
5)uncontrolable diabetes
6)severe heart disease such as myocardial infarction within six months and unstable angina.
7)uncontrolabel hypertension
8)pulmonary disease with over class 3 in American Society of Anesthesiologists physical status classification
9)Patients with a history of hypersensitivity for polyglycolic acid and collagen.
10)Patients with continuous systemic administration of steroid or immunosuppressant
11)Patients with the possibility of pregnancy or pregnancy
12)Patients who are unable oral administration of mecobalamin
13)Patients with gastrointestinal disorders inhibiting the absorption of mecobalamin
14)Patients with mental illness, alcoholism,drug addiction affecting the compliance with the clinical trial.
15)Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Nobuhiko
Middle name
Last name Oridate
Organization Yokohama City University
Division name Otorhinolaryngology, Head and Neck Surgery
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004
TEL 045-787-2800
Email noridate@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Arai
Organization Yokohama City University
Division name Otorhinolaryngology, Head and Neck Surgery
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004
TEL 045-787-2800
Homepage URL
Email yasuarai@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization TOYOBO CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama City University Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University
Address 3-9 Fukuura, Kanazawa-ku, Yokohama city, 236-0004
Tel 045-370-7627
Email nextjim1@yokohama-cu.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
2018 Year 04 Month 20 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
2018 Year 03 Month 15 Day
Date of IRB
2018 Year 03 Month 15 Day
Anticipated trial start date
2018 Year 04 Month 20 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 20 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035782

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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