UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017622 |
|---|---|
| Receipt number | R000020385 |
| Scientific Title | A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial. |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2016/07/11 09:31:48 |
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Basic information
Public title
A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial.
Acronym
A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial.
Scientific Title
A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial.
Scientific Title:Acronym
A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial.
Region
| Japan |
Condition
Condition
Tympanic membrane perforation(TMP)
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Closure of tympanic membrane perforation in the observation period at16 wks
Key secondary outcomes
1) Closure of tympanic membrane perforation in the observation period at 4 wks
2) Improvement of hearing level in the observation period at 4 wks and 16 wks
3) Air-bone gap in the observation period at 4 wks and 16 wks
4) The defference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
5) Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
(The rest is omitted)
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
Regenerative treatment of tympanic membrane
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Written informed concent obtained
2) At the time of obtaining informed consent, Ages ranged from over 20 to 80
3) At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months
(perforation in both ears is excluded)
Key exclusion criteria
1) TMP caused by burn or radiation therapy
2) In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
3) Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
4) No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
5) History of tympanoplasty
6) A Part of the eardrum adhered to tympanic cavity
7) By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration)
8) Abnormality in the chain and ear ossicles
9) Air-bone gap difference more than 25dB by patch hearing test
10) Unable to see whole edge of TMP due to narrow external auditory canal
11) Unable to wash out Ear drops during the treatment period
12) Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
13) Presenting with autoimmune disease
14) History of malignancy within 3 years prior to obtained informed concent
15) Administration of immunosuppressive agent or anti-cancer-agent
16) History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others
17) Though out the period from screening to treatment, patient who is unable to
wash out "Thrombolytic agent", "Anticoagulant", "Anti-platelet agent", "Procoagulant agent", "anti-line solvent"and"aprotinin formulation"
Target sample size
20
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
+81663128824
kanemaru@ent.kuhp.kyoto-u.ac.jp
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
+81663128824
Homepage URL
http://www.ibri-kobe.org/hospital/treatment/otolaryngology/
kanemaru@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Foundation for Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
先端医療振興財団 先端医療センター病院（兵庫県)/Institute of Biomedical Reserch and Innovation Hospital(Hyogo Pref)
慶應義塾大学病院（東京都）Keio University Hospital(Tokyo)
京都大学医学部附属病院（京都府）Kyoto University Hospital(Kyoto Pref)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020385
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
