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Effect of Eustachian Tube Balloon Dilatation via Trans nasal approach in patients with Eustachian Tube Dysfunction in Chronic Otitis media cases.

Efficacy of Trans nasal Eustachian Tube Balloon Dilatation in Patients with Eustachian Tube Dysfunction. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072725
Enrollment
39
Registered
2024-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H681- Obstruction of Eustachian tube

Interventions

Intervention1: EUSTACHIAN TUBE BALLOON CATHETER: After conducting a preoperative Eustachian Tube Function Test (ETFT), a transnasal Eustachian tube balloon dilatation is performed using a Eustachian t

Sponsors

Dr Sheth Kesha Kalpesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Abnormal Eustachian tube function test (Eustachian tube dysfunction) with or without that is irrespective of the Eustachian Tube Dysfunction Questionnaire (ETDQ) score 2.Eustachian Tube Dysfunction Questionnaire (ETDQ) score of more than or equal to 8 with Abnormal Eustachian tube function test

Exclusion criteria

Exclusion criteria: 1.Pregnant women 2.Normal Eustachian tube function test 3.Patients in whom ETFT is contraindicated 4.Patients unfit for surgery or general anaesthesia 5.Paediatric age group (due to organic causes example - adenoids or cleft palate) 6.Patients having ETDQ score of less than 8 with Normal Eustachian tube function test

Design outcomes

Primary

MeasureTime frame
Improvement in Eustachian Tube Function after Eustachian tube dilatation.Timepoint: Improvement in postoperative Eustachian tube function after 8 weeks of trans nasal Eustachian tube balloon dilatation.Improvement in postoperative Eustachian tube function after 8 weeks of transnasal Eustachian tube balloon dilatation.

Secondary

MeasureTime frame
There will be change in pressure in the Eustachian tube function test during swallowing & Valsalva maneuverTimepoint: After eight weeks post-operation, an Eustachian tube function test & other necessary audiological tests will be performed. Following this, a comparison will be made between the percentage of change in various parameters, including the Eustachian tube function test, Tympanometry, & the Eustachian Tube Dysfunction Questionnaire. Any value differences will be noted & their significance will be determined.

Countries

India

Contacts

Public ContactDr Hiren Soni

GMERS Medical College and Hospital, Gotri, Vadodara

drsoni7@gmail.com9825354642

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026