A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
NCT ID: NCT02550314
Last Updated: 2016-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2015-03-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NPC-18,FBG-18
Intervention drug:
NPC-18;trafermin(recombination) and gelatin spnge, combination drug FBG-18;fibrin glue
Usage:NPC-18 and FBG-18 is administered at the same time for regenerative treatment of tympanic membrane
fiblast,gelatin sponge,fibrin glue
Interventions
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fiblast,gelatin sponge,fibrin glue
Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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"
20 Years
80 Years
ALL
No
Sponsors
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Responsible Party
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Shin-ichi Kanemaru
director
Other Identifiers
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TRIENT1328
Identifier Type: -
Identifier Source: org_study_id