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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
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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"

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

    First Posted
    September 11, 2015
    Last Updated
    December 20, 2016
    Sponsor
    Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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    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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