| CTRI Number |
CTRI/2025/07/091165 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to assess benefit of Balloon dilatation of eustachian tube in patients with blocked ears and hearing loss due to eustachian tube blockage |
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Scientific Title of Study
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Efficacy of Balloon Dilatation of Eustachian tube (BDET) in conjunction with medical management compared to medical management alone in improvement of Tympanometry, Air Bone gap closure and Eustachian Tube Dysfunction Questionnaire (ETDQ) -7 Scoring in adults with chronic obstructive eustachian tube dysfunction (ETD): Open labelled, randomized, controlled, superiority trial
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharmistha Chakravarty |
| Designation |
Associate Professor, Department of ENT and Head Neck Surgery |
| Affiliation |
AIIMS Raipur |
| Address |
Department of ENT and Head Neck Surgery,
C Block, Ground Floor,
All India Institute of Medical Sciences, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
09163505756 |
| Fax |
|
| Email |
sharmisthachakravarty06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharmistha Chakravarty |
| Designation |
Associate professor, Department of ENT and Head Neck Surgery |
| Affiliation |
AIIMS Raipur |
| Address |
Department of ENT and Head Neck Surgery,
C Block, Ground Floor,
All India Institute of Medical Sciences, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
09163505756 |
| Fax |
|
| Email |
sharmisthachakravarty06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharmistha Chakravarty |
| Designation |
Associate professor, Department of ENT and Head Neck Surgery |
| Affiliation |
AIIMS Raipur |
| Address |
Department of ENT and Head Neck Surgery,
C Block, Ground Floor,
All India Institute of Medical Sciences, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
09163505756 |
| Fax |
|
| Email |
sharmisthachakravarty06@gmail.com |
|
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Source of Monetary or Material Support
|
| Room No. 1833, B Block, Fourth Floor, New administrative building, Department of ENT and Head Neck Surgery,
All India Institute of Medical Sciences, Tatibandh, Raipur, Chhattisgarh, India, Pincode- 492099 |
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Primary Sponsor
|
| Name |
AIIMS, RAIPUR |
| Address |
All India Institute of Medical Sciences,
Gate No. 1, Great Eastern Road,
Tatibandh, Raipur, Chhattisgarh, C.G. 492099 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharmistha Chakravarty |
AIIMS, Raipur |
Room No. 1833, B-Block, Fourth Floor,New Administrative Block, All India Institute of Medical Sciences,
Gate No.1, Great Eastern Road,
Tatibandh, Raipur,
Chhattisgarh 492099, India
Raipur
CHHATTISGARH |
09163505756
sharmisthachakravarty06@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Raipur |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H681||Obstruction of Eustachian tube, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balloon dilatation of Eustachian tube BDET arm |
After three months of conservative treatment with intranasal steroids(Fluticasone furoate 200 microgram nasal spray twice daily for two months, Valsalve manuevre three times daily for two months), cases which do not respond are categorised into refractory ETD. All Refractory ETD cases will be recruited in the study. After randomisation, the intervention arm will receive Balloon dilatation of eustachian tube along with medical management. The Balloon dilatation of Eustachian tube BDET will be performed by trans nasal endoscopic guided approach under general anaesthesia. During the procedure, a balloon catheter with 55 degree curved tip is introduced into the eustachian tube through the nose. The device has a distal endoscopic marker and proximal shaft marker to ensure safety and correct placement within the cartilaginous portion of the ET. Subsequently, it is inflated for 2 min, at 12 atmospheric pressure, and deflated before removing. A pre intervention nasal endoscopy will be performed to identify any anatomical obstruction. The dilatation will be performed two times at an interval of ten minutes in the same sitting. The intervention arm will also receive Intranasal steroids(Fluticasone furoate 200 microgram nasal spray twice daily and, Valsalva manuevre three times daily for additional two months. All patients shall be reassessed at 4 week, and 3 month, 6 month intervals for objective assessment of eustachian tube obstruction. |
| Comparator Agent |
Intranasal steroids(Fluticasone furoate 200 microgram nasal spray twice daily for two months, Valsalva manuevre three times daily for two months |
After three months of conservative treatment with intranasal steroids(Fluticasone furoate 200 microgram nasal spray twice daily for two months, Valsalve manuevre three times daily for two months), cases which do not respond are categorised into refractory ETD. All Refractory ETD cases will be recruited in the study. After randomisation, the control arm will receive Intranasal steroids(Fluticasone furoate 200 microgram nasal spray twice daily and, Valsalva manuevre three times daily for additional two months. All participants will be assessed at 4 week, 3 month, 6 month intervals for objective assessment of eustachian tube obstruction. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 60 years, Patients with who have moderate to severe ETD symptoms based on ETDQ 7 scoring and objective findings of retracted tympanic membrane and Type B or C tympanogram will be included as study participants,
Patients with chronic ETD who are refractory to two months of conservative treatment of nasal steroids and Valsalva. The ETD was considered refractory when the tympanometry results remained abnormal, either a C or B curve and the otomicroscopy revealed a tympanic membrane categorized as either retracted or with fluid.
|
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| ExclusionCriteria |
| Details |
1. Perforation or tympanostomy tube in the tympanic membrane
2. Cholesteatoma, retraction pockets with suspicion of cholesteatoma
3. Adhesive otitis media
4. Visible damage to the auditory ossicles
5. Lack of bone cover of the internal carotid artery documented by Computed tomography (CT) scan
6. Cleft lip and palate
7. Craniofacial syndrome including Downs syndrome, cystic fibrosis, primary ciliary dyskinesia, systemic immune deficiency, acute otitis media, sinonasal malignancy, prior radiation treatment in the head–neck region, and considerable heart–lung illness
8. Patients were excluded during the study if they received any steroid treatment aside from the study or had a tympanostomy tube inserted or perforated their tympanic membrane.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Tympanometry |
1 month, 3 months and 6 months post treatment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Median change of overall ETDQ 7 score from baseline, Tympanic membrane appearance and Pure Tone Audiometry results are the secondary endpoints to be assessed during interval visits. |
1 month, 3 months, and 6 months post treatment |
|
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Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This study is a randomized, open labelled, parallel group, superiority trial comparing the Efficacy of Balloon Dilatation of Eustachian tube BDET in conjunction with medical management compared to medical management alone in improvement of Tympanometry, Air Bone gap closure and Eustachian Tube Dysfunction Questionnaire ETDQ 7 Scoring in adults with chronic obstructive eustachian tube dysfunction ETD. All patients attending OPD of the department of ENT and Head Neck Surgery, at our institute with chronic Eustachian Tube Dysfunction ETD will be included in the study. Only those patients who have moderate to severe ETD symptoms based on ETDQ7 scoring and objective findings of retracted tympanic membrane and Type B or C tympanogram will be included as study participants. All the participants will be enrolled in the study after they have received three months of conservative treatment with nasal steroid spray and valsalva maneuvre and have shown persistent ETD after conservative treatment. Consented patients will be allocated into Balloon dilatation group with medical management, which is the intervention group and medical management alone group which will be the control group using computerised Random Allocation Software. All patients shall be reassessed at I month, 3 month, 6 month intervals for objective assessment of eustachian tube obstruction. The endpoints of the study are Tympanometry, Median change of overall ETDQ 7 score from baseline, Oto-endoscopy and Pure Tone Audiometry at the interval of I month, 3 months, and 6 months post treatment, comparing between the balloon dilatation with medical treatment group and medical treatment alone group. After the records of required sample size has been included, the data will be analysed by appropriate statistical methods of analysis. |