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A Prospective Multicenter Randomized Controlled Study for the Evaluation of Efficacy and Safety of Balloon Eustachian Tuboplasty for Patients with Chronic Otitis Media due to Obstructive Tube Dysfunction

Status Approved

First Submitted Date

2020/12/22
Registered Date

2021/01/25
Last Updated Date

2023/11/27

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005817
Unique Protocol ID	2020-1132
Public/Brief Title	A Prospective Multicenter Randomized Controlled Study for the Evaluation of Efficacy and Safety of Balloon Eustachian Tuboplasty for Patients with Chronic Otitis Media due to Obstructive Tube Dysfunction
Scientific Title	A Prospective Multicenter Randomized Controlled Study for the Evaluation of Efficacy and Safety of Balloon Eustachian Tuboplasty for Patients with Chronic Otitis Media due to Obstructive Tube Dysfunction
Acronym	BETCOM
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted approval

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-1132
Approval Date	2020-07-20
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hong Ju Park
Title	Dr
Telephone	+82-2-3010-3700
Affiliation	Asan Medical Center
Address	88 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea 05505
Contact Person for Public Queries
Name	Hong Ju Park
Title	Dr
Telephone	+82-2-3010-3700
Affiliation	Asan Medical Center
Address	88 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea 05505
Contact Person for Updating Information
Name	Hong Ju Park
Title	Dr
Telephone	+82-2-3010-3700
Affiliation	Asan Medical Center
Address	88 Olympic-ro 43-gil, Songpa-gu, Seoul, Korea 05505

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Completed
Date of First Enrollment	2021-01-19 Actual
Target Number of Participant	200
Primary Completion Date	2023-06-22 , Actual
Study Completion Date	2023-06-22 , Actual
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-01-19 ,
Recruitment Status by Participating Study Site 2
Name of Study	Samsung Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-02-10 ,
Recruitment Status by Participating Study Site 3
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Completed
Date of First Enrollment	2021-02-10 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	2014X52

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	University of Ulsan
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	In Korea, there are still insufficient research data on balloon Eustachian tuboplasty, so patients with Eustachian tube dysfunction have no other treatment options other than ventilation tube insertion. This study aims to prove the efficacy and safety of a balloon catheter developed in Korea for the treatment of patients with recurrent otitis media with effusion, chronic otitis media, earfullness, and hearing loss, targeting patients with otitis media caused by ear stenosis disease through a prospective randomized controlled comparative study.

Study Summary Information

Lay Summary

In Korea, there are still insufficient research data on balloon Eustachian tuboplasty, so patients with Eustachian tube dysfunction have no other treatment options other than ventilation tube insertion. This study aims to prove the efficacy and safety of a balloon catheter developed in Korea for the treatment of patients with recurrent otitis media with effusion, chronic otitis media, earfullness, and hearing loss, targeting patients with otitis media caused by ear stenosis disease through a prospective randomized controlled comparative study.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Cross-over
Blinding/Masking	Open
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Balloon Eustachian tuboplasty and active control treatment are prescribed at the same time. Two weeks after balloon Eustachian tuboplasty, we examine the surgical site and whether there is any adverse reaction. Three months after balloon Eustachian tuboplasty, pure tone audiometry, speech audiometry, impedance audiometry, Valsalva test, and ETDQ-7 are conducted. The same is repeated at 1 year. Active control medications are prescribed. After 3 months, pure tone audiometry, speech audiometry, impedance audiometry, Valsalva test, and ETDQ-7 are conducted. If there is no improvement in the Eustachian tube function after 3 months, the patient can undergo balloon Eustachian tuboplasty if desired. The stability and efficacy are checked after 2 weeks, 3 months, and 1 year in the same way as in the experimental group.
Number of Arms	2
Arm 1	Arm Label Eustachian tube dysfunction
	Target Number of Participant 100
	Arm Type Experimental
	Arm Description Balloon Eustachian tuboplasty and active control treatment are prescribed at the same time. Two weeks after balloon Eustachian tuboplasty, we examine the surgical site and whether there is any adverse reaction. Three months after balloon Eustachian tuboplasty, pure tone audiometry, speech audiometry, impedance audiometry, Valsalva test, and ETDQ-7 are conducted. The same is repeated at 1 year.
Arm 2	Arm Label Eustachian tube dysfunction
	Target Number of Participant 100
	Arm Type No intervention
	Arm Description Active control medications are prescribed. After 3 months, pure tone audiometry, speech audiometry, impedance audiometry, Valsalva test, and ETDQ-7 are conducted. If there is no improvement in the Eustachian tube function after 3 months, the patient can undergo balloon Eustachian tuboplasty if desired. The stability and efficacy are checked after 2 weeks, 3 months, and 1 year in the same way as in the experimental group.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H66.90)Otitis media, unspecified, unilateral or unspecified ① Patients over 19 years and under 80 years ② Patients with chronic otitis media (including exudative otitis media and chronic otitis media with cholesteatoma) associated with Eustachian tube dysfunction for more than 6 months ③ In the case of a person who has previously undergone ventilation tube insertion, mastoidectomy, or tympanoplasty, patients with middle ear effusion or deterioration of Eustachian tube function continuously for at least 1 month after surgery ④ In case the patient agrees to participate in clinical research and signs the written consent
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~80Year
	Description ① Patients over 19 years and under 80 years ② Patients with chronic otitis media (including exudative otitis media and chronic otitis media with cholesteatoma) associated with Eustachian tube dysfunction for more than 6 months ③ In the case of a person who has previously undergone ventilation tube insertion, mastoidectomy, or tympanoplasty, patients with middle ear effusion or deterioration of Eustachian tube function continuously for at least 1 month after surgery ④ In case the patient agrees to participate in clinical research and signs the written consent
Exclusion Criteria	① Patulous Eustachian tube dysdunction patients ② Patients with fluctuating sensorineural hearing loss ③ Patients with acute otitis media ④ Patients with a history of cleft palate or cleft palate surgery ⑤ Patients with a history of craniofacial deformities ⑥ Patients who are pregnant or nursing ⑦ In case of wanting alternative treatment (conservative treatment or ventilation tube insertion) ⑧ If the investigator judges that the patient is not suitable for this clinical trial or may increase the risk related to participation in the study
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Valsava maneuver
Timepoint	3 months, 1 year after surgery
Secondary Outcome(s) 1
Outcome	ETDQ-7
Timepoint	3 months, 1 year after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2023. 12
Way of Sharing	Other (will be published)

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