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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006585
Receipt No. R000007779
Scientific Title Regenerative treatment for tympanic membrane perforation
Date of disclosure of the study information 2011/10/21
Last modified on 2011/10/21

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Basic information
Public title Regenerative treatment for tympanic membrane perforation
Acronym Regenerative treatment for tympanic membrane perforation
Scientific Title Regenerative treatment for tympanic membrane perforation
Scientific Title:Acronym Regenerative treatment for tympanic membrane perforation
Region
Japan

Condition
Condition Perforation of tympanic membrane
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of this tissue engineering therapy for the treatment of tympanic membrane perforation (TMP)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Closure of tympanic membrane perforation 3 months after the treatment
Key secondary outcomes 1)Efficacy
Improvement of hearing level 3 months after the treatment
2)Safety
Adverse events

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
Medicine Maneuver
Interventions/Control_1 Tissue engineering therapy for the treatment of tympanic membrane perforation
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. Chronic otitis media with TMP OR
Old traumatic TMP, OR Residual TMP following surgical treatments, OR TMP after the insertion of a ventilation tube in patients with otitis media with effusion
2. On microscope, perfect dry TMP and no active inflammation in the inner, middle, or outer ear; no invasion of epitherium into middle ear vaity and no cholesteatoma
3. Based on temporal bone CT,
a. Well pneumatized mastoid (MC2 or MC3) defined by the Japan Otological Society
b. Absence of abnormal soft tissue mass
c. Normal ossicles
4. Hearing improvement upon patch test
5. Signed written informed consent to participate in the trial
Key exclusion criteria 1. TMP due to burn
2. Postoperatively re-perforated TM or patients who underwent surgeries in the inner, middle, or outer ear
3. Poor development of the mastoid pneumatization(MC0 or MC1) defined by the Japan Otological Society
4. Unable to see the whole edge of TMP due to narrow external auditory canal
5. Active infection or inflammation in the inner or middle ear
6. Uncontrolled diabetes mellitus or autoimmune diseases
7. Patients treated with immunosuppressive or anticancer drugs
8. Allergy to drugs (lidocaine, Trafermin/Fibrast, fibrin glue(Bolheal, Beriplast)) or gelatin sponge(Spongel)
9. Requirement for antiplatelet or anticoagulant drugs
10. Females who are pregnant or desire childbearing
11. Patients judged as being inappropriate for this trial by investigators
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ichi Kanemaru, M.D., Ph.D.
Organization Medical Research Institute, Kitano Hospital
Division name Department of Otolaryngology&#8211;Head and Neck Surgery
Zip code
Address 2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan
TEL +81-6-6312-8824
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ichi Kanemaru, M.D., Ph.D.
Organization Medical Research Institute, Kitano Hospital
Division name Department of Otolaryngology&#8211;Head and Neck Surgery
Zip code
Address 2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan
TEL +81-6-6312-8824
Homepage URL
Email kanemaru@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute The Foundation for Biomedical Research and Innovation
Institute
Department

Funding Source
Organization The Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Medical Research Institute, Kitano Hospital
Kobe City Medical Center General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 10 Month 21 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
2011 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 21 Day
Last modified on
2011 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007779

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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