UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006585
Receipt number R000007779
Scientific Title Regenerative treatment for tympanic membrane perforation
Date of disclosure of the study information 2011/10/21
Last modified on 2011/10/21 14:09:50

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Basic information

Public title

Regenerative treatment for tympanic membrane perforation

Acronym

Regenerative treatment for tympanic membrane perforation

Scientific Title

Regenerative treatment for tympanic membrane perforation

Scientific Title:Acronym

Regenerative treatment for tympanic membrane perforation

Region

Japan


Condition

Condition

Perforation of tympanic membrane

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of this tissue engineering therapy for the treatment of tympanic membrane perforation (TMP)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Closure of tympanic membrane perforation 3 months after the treatment

Key secondary outcomes

1)Efficacy
Improvement of hearing level 3 months after the treatment
2)Safety
Adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Tissue engineering therapy for the treatment of tympanic membrane perforation

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Chronic otitis media with TMP OR
Old traumatic TMP, OR Residual TMP following surgical treatments, OR TMP after the insertion of a ventilation tube in patients with otitis media with effusion
2. On microscope, perfect dry TMP and no active inflammation in the inner, middle, or outer ear; no invasion of epitherium into middle ear vaity and no cholesteatoma
3. Based on temporal bone CT,
a. Well pneumatized mastoid (MC2 or MC3) defined by the Japan Otological Society
b. Absence of abnormal soft tissue mass
c. Normal ossicles
4. Hearing improvement upon patch test
5. Signed written informed consent to participate in the trial

Key exclusion criteria

1. TMP due to burn
2. Postoperatively re-perforated TM or patients who underwent surgeries in the inner, middle, or outer ear
3. Poor development of the mastoid pneumatization(MC0 or MC1) defined by the Japan Otological Society
4. Unable to see the whole edge of TMP due to narrow external auditory canal
5. Active infection or inflammation in the inner or middle ear
6. Uncontrolled diabetes mellitus or autoimmune diseases
7. Patients treated with immunosuppressive or anticancer drugs
8. Allergy to drugs (lidocaine, Trafermin/Fibrast, fibrin glue(Bolheal, Beriplast)) or gelatin sponge(Spongel)
9. Requirement for antiplatelet or anticoagulant drugs
10. Females who are pregnant or desire childbearing
11. Patients judged as being inappropriate for this trial by investigators

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-ichi Kanemaru, M.D., Ph.D.

Organization

Medical Research Institute, Kitano Hospital

Division name

Department of Otolaryngology&#8211;Head and Neck Surgery

Zip code


Address

2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan

TEL

+81-6-6312-8824

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shin-ichi Kanemaru, M.D., Ph.D.

Organization

Medical Research Institute, Kitano Hospital

Division name

Department of Otolaryngology&#8211;Head and Neck Surgery

Zip code


Address

2-4-20 Ohgimachi, Kitaku, Osaka, 530-8480, Japan

TEL

+81-6-6312-8824

Homepage URL


Email

kanemaru@ent.kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

The Foundation for Biomedical Research and Innovation

Institute

Department

Personal name



Funding Source

Organization

The Foundation for Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Medical Research Institute, Kitano Hospital
Kobe City Medical Center General Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2011 Year 09 Month 22 Day

Date of IRB


Anticipated trial start date

2011 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 10 Month 21 Day

Last modified on

2011 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name