UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010882
Receipt number R000012734
Scientific Title Clinical research of the bone conductive hearing system.
Date of disclosure of the study information 2013/06/06
Last modified on 2022/12/06 12:33:48

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Basic information

Public title

Clinical research of the bone conductive hearing system.

Acronym

Bone conductive hearing aid implantation

Scientific Title

Clinical research of the bone conductive hearing system.

Scientific Title:Acronym

Bone conductive hearing aid implantation

Region

Japan


Condition

Condition

Bilateral conductive hearing loss.

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Hearing loss causes serious disability of smooth communication, so the appropriate medical treatment is important to get out from this situation. Bilateral conductive hearing loss was usually treated by fitting hearing aid or ossicular reconstruction surgely but in some case, the improvement of hearing ability was not sufficient for smooth communication. The bone conductive hearing implantation will improve the hearing ability and communication ability of bilateral bone conductive hearing loss patients. In this clinical research, we confirm the BONEBRIDGE system benefit in Japanese bilateral conductive hearing loss patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The therapeutic effects are evaluated at 6 month after the BONEBRIDGE operation, using free field audiometry. In this test, marked recovery is defined as any recovery in the mean hearing level at the 500, 1000 and 2000Hz

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The bone conductive hearing implantation is performed under general anesthesia. For the bone conductive implantation, a bed for FMT (Floating
Mass Transducer) is drilled in the sinodural angle and fixed with two cortical screws. The receiver coil of
the BCI is placed on the bone under the periosteum. The implant system can be activated, after the
swelling of the skin flap above the implant has reduced.

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

Revision tympanoplasty, ear canal stenosis or
chronically draining ears where conventional hearing
aids are not suitable due to poor wearability,
feedback problems or poor sound quality.
Congenital malformations where ear canals are absent
and cannot be restored through conventional surgery.

Key exclusion criteria

The patients with severe bone malformation and did not have enough setting space for bone conductive implantation.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-ichi Usami

Organization

Shinshu university school of medicine

Division name

Department of Otorhinolaryngology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shin-ichi Usami

Organization

Shinshu University School of Medicine

Division name

Department of Otorhinolaryngology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano, JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Shinshu university hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

MED-EL Electro-Medizinische Gerate GMBH

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

2013 Year 06 Month 06 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

Completed

Date of protocol fixation

2013 Year 05 Month 10 Day

Date of IRB

2013 Year 06 Month 04 Day

Anticipated trial start date

2013 Year 06 Month 06 Day

Last follow-up date

2018 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 05 Day

Last modified on

2022 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012734


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name