UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial.
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shin-ichi Kanemaru, M.D., Ph.D
Organization	Medical Research Institute, Kitano Hospital
Division name	Department of Otolaryngology & Head and Neck Surgery
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	Shin-ichi Kanemaru, M.D., Ph.D
Organization	Medical Research Institute, Kitano Hospital
Division name	Department of Otolaryngology & Head and Neck Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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