| CTRI Number |
CTRI/2026/02/102975 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of preoperative CT scan to predict visibility of Round window (a key inner ear structure) during Cochlear implant surgery |
|
Scientific Title of Study
|
Correlation of Preoperative High Resolution Computed Tomography Temporal Bone Parameters with Transcanal visibility of Round Window during Cochlear Implantation by Veria technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMS/IEC/BMR/2025/5593 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PUJA SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Otorhinolaryngology,
Room no 408, 4th floor A block, OPD building AIIMS Jodhpur,
Basni Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
6290991069 |
| Fax |
|
| Email |
pujasharmamedical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMIT GOYAL |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Otorhinolaryngology,
Room no 410, 4th floor A block, OPD building AIIMS Jodhpur,
Basni Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9649954000 |
| Fax |
|
| Email |
meetugoyal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PUJA SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
Department of Otorhinolaryngology,
Room no 408, 4th floor A block, OPD building AIIMS Jodhpur,
Basni Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
6290991069 |
| Fax |
|
| Email |
pujasharmamedical@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur
Department of Otorhinolaryngology,
Room no 408, 4th floor A block, OPD building AIIMS Jodhpur,
Basni Phase-II, Jodhpur, Rajasthan-342005 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
All India Institute of Medical Sciences, Jodhpur
Department of Otorhinolaryngology,
Room no 408, 4th floor A block, OPD building AIIMS Jodhpur,
Basni Phase-II, Jodhpur, Rajasthan-342005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PUJA SHARMA |
All India Institute of Medical Sciences Jodhpur |
Department of Otorhinolaryngology,
Room no 408, 4th floor A block, OPD building AIIMS Jodhpur,
Basni Phase-II, Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN |
6290991069
pujasharmamedical@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H905||Unspecified sensorineural hearingloss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Cochlear Implantation by Veria technique |
|
| ExclusionCriteria |
| Details |
Any external, middle and inner ear anomaly
History of prior ear surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between preoperative HRCT temporal bone parameters and intraoperative transcanal visibility of the round window during cochlear implantation performed by the Veria technique. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictive value of the angle between the External Auditory Canal (EAC) and the round window (as measured on preoperative HRCT) in determining the ease of intraoperative transcanal round window visibility. |
2 years |
| Association between round window niche shape (categorized as ‘O’-shaped or ‘C’-shaped) on HRCT and intraoperative round window visibility. |
2 years |
| Correlation of round window niche orientation on HRCT with intraoperative transcanal visibility. |
2 years |
| Influence of cochlear rotation and cochlear axis orientation on transcanal round window visualization during surgery. |
2 years |
| Effect of degree of mastoid pneumatization on intraoperative transcanal round window visibility. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the relationship between preoperative high-resolution computed tomography (HRCT) temporal bone parameters and intraoperative transcanal visibility of the round window during cochlear implantation performed using the Veria technique. The primary focus is to assess the correlation between radiological findings and surgical visibility of the round window. Secondary objectives include evaluating the predictive utility of the angle between the external auditory canal and the round window, assessing round window niche shape and orientation, analyzing cochlear rotation and axis, and determining the influence of mastoid pneumatization. The study seeks to identify reliable preoperative HRCT predictors that can assist in surgical planning and improve intraoperative outcomes in cochlear implantation. |