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Completed

NCT Number: NCT02550314

A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18

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

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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

fiblast,gelatin sponge,fibrin glue

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Registry information

Official study title

A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2015
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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