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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017622
Receipt No. 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

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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
Email 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/
Email kanemaru@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Foundation for Biomedical Research and Innovation
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020385

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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