Clinical trial: A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18 (NCT02550314)

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"
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment