UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031097 |
|---|---|
| Receipt number | R000035516 |
| Scientific Title | Surgical reconstruction using the human dried amnion of the otolaryngology region |
| Date of disclosure of the study information | 2018/02/08 |
| Last modified on | 2019/08/06 10:59:27 |
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Basic information
Public title
Surgical reconstruction using the human dried amnion of the otolaryngology region
Acronym
Surgical reconstruction using the human dried amnion of the otolaryngology region
Scientific Title
Surgical reconstruction using the human dried amnion of the otolaryngology region
Scientific Title:Acronym
Surgical reconstruction using the human dried amnion of the otolaryngology region
Region
| Japan |
Condition
Condition
The patients with the mucosa defect of the otolaryngology region receiving surgical treatment
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is a purpose that a safe, effective therapy is established by using the dried amnion as filling materials to the mucosa defect in the otolaryngology region.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Day to Epithelization completion after treatment
(The epithelization completion defines "the point in time when the summation of each item score became 0" as "epithelization completion" at each evaluation point of "pain, otorrhea, adhesion, color, the neovascularisation".)
Key secondary outcomes
1)Pain
2)otorrhea
3)adhesion
4)color
5)neovascularisation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dried amnion are returned by a saline (or it is the same state) and the affected part are covered by the amnion.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients of (at the agreement acquisition) 20 years old or older age
2) The patients who relatively have good overall status
3) The patients who is judged to be available for observation, the testing that conformed to a study enforcement plan and a survey
Key exclusion criteria
1) The person who judged a doctor to have difficulty in hospital visiting and coming home safely for study period
2) The patients who complicate infection with the activity
3) The patients who plan the enforcement of the operation for the evaluation department effective during study period in (perform a study of the agreement acquisition with starting)
4) For the group medicine of the planned drug (Xylocaine anesthetic agent, Achromycin) to use during study period, is the patients with a history of the drug allergy
5) The patients (saying that, however, the subjects who do not receive the study drug are possible) who participated in other studies or clinical studies within six months
6) Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception
7) The patients who judged a doctor to be inadequate as an object of this study in testing at agreement acquisition
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shojyaku |
| Middle name | |
| Last name | Hideo |
Organization
University of Toyama
Division name
Dept. of Otolaryngology
Zip code
930-0194
Address
Sugitani 2630, Toyama City
TEL
076-434-7368
hshojaku@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shojyaku |
| Middle name | |
| Last name | Hideo |
Organization
University of Toyama
Division name
Dept. of Otolaryngology
Zip code
930-0194
Address
Sugitani 2630, Toyama City
TEL
076-434-7367
Homepage URL
hshojaku@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Miyagi Cancer Center
Name of secondary funder(s)
Miyagi Cancer Center
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
Sugitani2630, Toyama City
Tel
076-434-7145
kanakada@med.u-toyama.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 | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2008 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2008 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2008 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | 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 | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035516
