Clinical trial NCT02550314: A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
Official title: A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tympanic Membrane Perforation
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.


Eligibility criteria: 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)

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"

Primary outcomes:
measure: Closure of tympanic membrane perforation in the observation period at16 wks
timeFrame: Closure of tympanic membrane perforation in the observation period at16 wks
Secondary outcomes:
measure: Closure of tympanic membrane perforation in the observation period at 4 wks
timeFrame: Closure of tympanic membrane perforation in the observation period at 4 wks
measure: Improvement of hearing level in the observation period at 4 wks and 16 wks
timeFrame: Improvement of hearing level in the observation period at 4 wks and 16 wks
measure: Air-bone gap in the observation period at 4 wks and 16 wks
timeFrame: Air-bone gap in the observation period at 4 wks and 16 wks
measure: The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
timeFrame: The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks
measure: Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
timeFrame: Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
Other outcomes:
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