A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
Primary Purpose
Tympanic Membrane Perforation
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
fiblast,gelatin sponge,fibrin glue
Sponsored by
About this trial
This is an interventional treatment trial for Tympanic Membrane Perforation
Eligibility Criteria
Inclusion Criteria:
- Written informed concent obtained
- At the time of obtaining informed consent, Ages ranged from over 20 to 80
- 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:
- TMP caused by burn or radiation therapy
- In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
- Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
- No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
- History of tympanoplasty
- A Part of the eardrum adhered to tympanic cavity
- By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration)
- Abnormality in the chain and ear ossicles
- Air-bone gap difference more than 25dB by patch hearing test
- Unable to see whole edge of TMP due to narrow external auditory canal
- Unable to wash out Ear drops during the treatment period
- Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
- Presenting with autoimmune disease
- History of malignancy within 3 years prior to obtained informed concent
- Administration of immunosuppressive agent or anti-cancer-agent
- History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others
- 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"
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPC-18,FBG-18
Arm Description
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
Outcomes
Primary Outcome Measures
Closure of tympanic membrane perforation in the observation period at16 wks
Secondary Outcome Measures
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
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
Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
Full Information
NCT ID
NCT02550314
First Posted
September 11, 2015
Last Updated
December 20, 2016
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
1. Study Identification
Unique Protocol Identification Number
NCT02550314
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanic Membrane Perforation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-18,FBG-18
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
fiblast,gelatin sponge,fibrin glue
Primary Outcome Measure Information:
Title
Closure of tympanic membrane perforation in the observation period at16 wks
Time Frame
Closure of tympanic membrane perforation in the observation period at16 wks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed concent obtained
At the time of obtaining informed consent, Ages ranged from over 20 to 80
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:
TMP caused by burn or radiation therapy
In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
History of tympanoplasty
A Part of the eardrum adhered to tympanic cavity
By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration)
Abnormality in the chain and ear ossicles
Air-bone gap difference more than 25dB by patch hearing test
Unable to see whole edge of TMP due to narrow external auditory canal
Unable to wash out Ear drops during the treatment period
Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
Presenting with autoimmune disease
History of malignancy within 3 years prior to obtained informed concent
Administration of immunosuppressive agent or anti-cancer-agent
History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others
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"
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
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