- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02550314
A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18
December 20, 2016 updated by: Shin-ichi Kanemaru, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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"
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NPC-18,FBG-18
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 at16 wks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
September 11, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 15, 2015
Study Record Updates
Last Update Posted (Estimate)
December 22, 2016
Last Update Submitted That Met QC Criteria
December 20, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRIENT1328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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