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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026634
Receipt No. R000030554
Scientific Title A multicenter clinical study of functional tracheal remodeling with an artificial trachea
Date of disclosure of the study information 2017/03/27
Last modified on 2019/05/23

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Basic information
Public title A multicenter clinical study of functional tracheal remodeling with an artificial trachea
Acronym Functional Remodeling with Artificial Trachea (FRAT)
Scientific Title A multicenter clinical study of functional tracheal remodeling with an artificial trachea
Scientific Title:Acronym Functional Remodeling with Artificial Trachea (FRAT)
Region
Japan

Condition
Condition Malignancies, inflammatory diseases, traumas
Classification by specialty
Chest surgery Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate a efficacy and safety of an artificial trachea
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence (or absence) of tracheostomy stoma at 12 weeks after the procedure
Key secondary outcomes Degree of airway stenosis at 12 weeks after the procedure
Degree of re-epithelialization of a luminal side of the artificial trachea at 12 weeks after the procedure
modified Rankin Scale
Respiratory assessment scale
EQ5D-5L
V-RQOL

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 tracheal reconstruction using an artificial trachea
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
75 years-old >
Gender Male and Female
Key inclusion criteria Be able to comply with the trial protocol.
Provide written informed consent.
Have been diagnosed that (1) or (2)
(1) tracheal stoma was not able to be reconstructed with existing treatment options.
(2) no less than a half of the tracheal cartilage as well as three tracheal rings should be affected through resection of malignancies.
Key exclusion criteria Have a bilateral vocal fold palsy.
Have a severe cardiovascular, hematological, hepatic, digestive, renal, pulmonary, endocrine, neurological or psychiatric diseases.
Severe hemorrhage or shock.
Severe bacterial, viral or fungal infections.
Keloid diathesis.
A history of irradiation to the neck.
Be indicated for any other treatments.
Have a history of allergic reaction to a porcine collagen or polypropylene.
Have participated in any other clinical trials, and an investigational agent has been administered within 12 weeks.
Pregnant, lactating, or willing to be pregnant during the trial.
Be concluded not eligible to enter the trial by a principle investigator or sub-investigator.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Koichi
Organization Graduate school of Medicine, Kyoto University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code 606-8507
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL +81-75-751-3346
Email omori@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yo
Middle name
Last name Kishimoto
Organization Graduate school of Medicine, Kyoto University
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code 606-8507
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL +81-75-751-3346
Homepage URL
Email y_kishimoto@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Kyoto University Hospital
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel 075-751-4899
Email trans@kuhp.kyoto-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 京都大学医学部附属病院(京都府)
倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 27 Day

Related information
URL releasing protocol http://www.kuhp.kyoto-u.ac.jp/~ent/ClinicalTrial/Jinkoukikan/about.html
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
2016 Year 11 Month 28 Day
Date of IRB
2017 Year 02 Month 21 Day
Anticipated trial start date
2017 Year 03 Month 27 Day
Last follow-up date
2017 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 21 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030554

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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