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The Therapeutic Effect of BET in COM With ETD

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ClinicalTrials.gov Identifier: NCT03440710
Recruitment Status : Not yet recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

Brief Summary:

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?


Condition or disease Intervention/treatment Phase
Balloon Eustachian Tuboplasty Procedure: BET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Effect of Balloon Eustachian Tuboplasty (BET) in Chronic Otitis Media (COM) With Eustachian Tube Dysfunction (ETD)
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: with BET
with BET and Tympanoplast
Procedure: BET
Balloon Eustachian Tuboplasty

without BET
with Tympanoplast only
Procedure: BET
Balloon Eustachian Tuboplasty




Primary Outcome Measures :
  1. Recurrence rate in chronic otitis media with eustachian tube dysfunction [ Time Frame: 6months after the surgery ]
    Recurrence rate in chronic otitis media with eustachian tube dysfunction: with BET vs without BET


Secondary Outcome Measures :
  1. Hearing change in chronic otitis media with eustachian tube dysfunction [ Time Frame: before the surgery, and 6months after the surgery ]
    Hearing outcome in chronic otitis media with eustachian tube dysfunction: with BET vs without BET

  2. The change of Eustachian tube function using TUBOMANOMETRY (TMM) [ Time Frame: before the surgery, and 6months after the surgery ]
    Eustachian tube function before and after surgery using TUBOMANOMETRY (TMM)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440710


Locations
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China, Shanghai
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University

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Responsible Party: Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03440710     History of Changes
Other Study ID Numbers: The Effect of BET in COM
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No