Status unknownNCT03440710Updated Feb 22, 2018

The Therapeutic Effect of BET in COM With ETD

An interventional study of BET in Balloon Eustachian Tuboplasty, sponsored by Eye & ENT Hospital of Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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?

Conditions studied

Balloon Eustachian Tuboplasty

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients who need tympanoplasty, with clear diagnosis of chronic otitis media, middle ear cholesteatoma;
Patients with eustachian tube dysfunction using TMM;
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

Exclusion Criteria:

Secondary chronic otitis media (after head and neck cancer radiotherapy);
Ipsilateral ear recurrence after surgical treatment, requiring secondary surgery;
Two tympanoplasty surgery;
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;
poor general health, with severe liver and kidney dysfunction, coagulation disorders, cardiovascular disease, neurological diseases can not tolerate surgery.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 60 participants (estimated)

Study arms

Experimental
with BET
with BET and Tympanoplast
Procedure: BET
Other
without BET
with Tympanoplast only
Procedure: BET

Interventions

ProcedureBET
Balloon Eustachian Tuboplasty

What researchers measure

Primary outcomes

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
Time frame: 6months after the surgery

Secondary outcomes

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
Time frame: 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)
Time frame: before the surgery, and 6months after the surgery

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03440710
Lead sponsor: Eye & ENT Hospital of Fudan University
Responsible party: Sponsor
First posted: Feb 22, 2018
Start date: Jun 1, 2018 (estimated)
Primary completion: May 30, 2019 (estimated)
Completion: Dec 30, 2019 (estimated)
Last update: Feb 22, 2018

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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