UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026634 |
|---|---|
| Receipt number | 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 18:11:02 |
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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
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
y_kishimoto@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030554
