The Therapeutic Effect of BET in COM With ETD

The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)

Currently, surgical treatment of patients with chronic otitis media is one of the most important treatment methods. However, the current results show that some patients with eustachian tube dysfunction can't reconstruct the gas-containing structure of the middle ear after operation.

This is a randomized controlled trial that aims to evaluate the therapeutic effect of balloon eustachian tuboplasty (BET) for the treatment in chronic otitis media (COM) with eustachian tube dysfunction (ETD). This future study will aim to address the question: Does BET gain better recovery of auditory function and lower recurrence rate in chronic otitis media with eustachian tube dysfunction?

Study Overview

• Status: Unknown
• Conditions: Balloon Eustachian Tuboplasty
• Intervention / Treatment: Procedure: BET

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
2. Patients with eustachian tube dysfunction using TMM;
3. Subjects or their legal representatives can understand the purpose of the study, show sufficient compliance with the research protocol, and sign the informed consent form.

Exclusion Criteria:

1. Secondary chronic otitis media (after head and neck cancer radiotherapy);
2. Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
3. Two tympanoplasty surgery;
4. Typical allergic rhinitis, nasal endoscopy or imaging studies suggest chronic rhinosinusitis, nasal polyps and other short-term eustachian tube function of a greater impact on the disease;
5. poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with BET; with BET and Tympanoplast	Procedure: BET; Balloon Eustachian Tuboplasty
Other: without BET; with Tympanoplast only	Procedure: BET; Balloon Eustachian Tuboplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate in chronic otitis media with eustachian tube dysfunction	Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET	6months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing change in chronic otitis media with eustachian tube dysfunction	Hearing outcome in chronic otitis media with eustachian tube dysfunction: with BET vs without BET	before the surgery, and 6months after the surgery
The change of Eustachian tube function using TUBOMANOMETRY (TMM)	Eustachian tube function before and after surgery using TUBOMANOMETRY (TMM)	before the surgery, and 6months after the surgery

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): May 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: February 11, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: The Effect of BET in COM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No