UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006585 |
|---|---|
| Receipt number | 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 14:09:50 |
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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–Head and Neck Surgery
Zip code
Address
2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan
TEL
+81-6-6312-8824
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–Head and Neck Surgery
Zip code
Address
2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan
TEL
+81-6-6312-8824
Homepage URL
kanemaru@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
The Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007779
