UMIN-CTR Clinical Trial

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
Email	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
Email	hshojaku@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035516