To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Closure of tympanic membrane perforation in the observation period at16 wks
Time frame: Closure of tympanic membrane perforation in the observation period at16 wks
Closure of tympanic membrane perforation in the observation period at 4 wks
Time frame: Closure of tympanic membrane perforation in the observation period at 4 wks
Improvement of hearing level in the observation period at 4 wks and 16 wks
Time frame: Improvement of hearing level in the observation period at 4 wks and 16 wks
Air-bone gap in the observation period at 4 wks and 16 wks
Time frame: Air-bone gap in the observation period at 4 wks and 16 wks
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
Time frame: 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
Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
Time frame: Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
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