| CTRI Number |
CTRI/2021/11/038186 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trials of Implantable Medical device to address Disabled Hearing Loss. |
|
Scientific Title of Study
|
IMPLANTATION WITH MEDTECH COCHLEAR IMPLANT SYSTEM IN ADULTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCL/Pilot/I180074/2020, Version No. 1.0, Date: 21-SEP-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prahlada NB |
| Designation |
Professor, Department of Otorhinolaryngology - ENT & Neck Surgery |
| Affiliation |
Basaveshwara Medical College and Hospital |
| Address |
ENT Block
Housing Board Colony
SJM campus NH4 Bypass
Chitradurga
KARNATAKA
577501
India |
| Phone |
9342310854 |
| Fax |
|
| Email |
prahladnb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kalirajan Bose |
| Designation |
Program Manager / Engineering - R&D |
| Affiliation |
HCL TECHNOLOGIES LIMITED |
| Address |
D12 & 12B, Sidco Industrial Estate,Ambattur Industrial Estate
Chennai
TAMIL NADU
600058
India |
| Phone |
9840943236 |
| Fax |
|
| Email |
kalirajanb@hcl.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreedhar Bunga |
| Designation |
Subject Matter Expert/ Head Clinical CoE |
| Affiliation |
HCL TECHNOLOGIES LIMITED |
| Address |
D12 & 12B, Sidco Industrial Estate,Ambattur Industrial Estate
Chennai
TAMIL NADU
600058
India |
| Phone |
9704487909 |
| Fax |
|
| Email |
sreedhar.bunga@hcl.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HCL TECHNOLOGIES LIMITED |
| Address |
D12 & 12B, Sidco Industrial Estate,
Ambattur Industrial Estate, Chennai
Tamil Nadu, 600058, India
|
| Type of Sponsor |
Other [Indian multinational information technology (IT) services and consulting company] |
|
|
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 Prahlada NB |
Basaveshwara Medical College and Hospital |
Professor, Department of Otorhinolaryngology - ENT & Neck Surgery
ENT Block
Housing Board Colony
SJM campus NH4 Bypass Chitradurga
Karnataka - 577501 India
Chitradurga
KARNATAKA |
9342310854
prahladnb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, BMCH Registration No. ECR/1218/Inst/KA/2019 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H903||Sensorineural hearing loss, bilateral, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MedTech Cochlear Implant System |
Unilateral cochlear implantation of HCL Cochlear
Implant System in patients with severe to profound bilateral hearing loss in adults |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.18 years of age or older
2.Severe-to-profound, sensorineural hearing loss (>70 dB), determined by pure tune at 500Hz, 1000Hz and 2000Hz
3.bilateral or Postlingual onset of severe or profound hearing loss
4.Limited benefit from appropriate binaural hearing aids (verified by standard clinical practice), as defined by aided test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on tests of open set sentence recognition.
I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated
5.Moderate to profound hearing loss in the low frequencies and profound (≥ 90 dB HL) hearing loss in the mid to high speech frequencies
6.eBERA – Electrical brainstem evoked response audiometry to ensure benefit from the Implant. eBERA can be performed during surgery itself.
|
|
| ExclusionCriteria |
| Details |
1.Sensorineural severe-to-profound hearing loss greater than 20 years at ≥ 2 kHz and above
2.Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted
3.Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
4.Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
5.Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway (audio Neuropathy Spectrum disorder).
6.Active middle-ear infection
7.Tympanic membrane perforation
8.Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
9.Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak
10.Patients with recurrent episodes of bacterial meningitis
11.Any other Cochlear Implant
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Performance – To evaluate preoperative to 3 month’s post-activation performance outcomes in the best unilateral listening condition
Safety – Report of medical/surgical and device related adverse events with regard to type, frequency and seriousness at 3 months post activation
|
Preoperative to 3 month’s post-activation |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="3"
Sample Size from India="3"
Final Enrollment numbers achieved (Total)= "3"
Final Enrollment numbers achieved (India)="3" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2021 |
| Date of Study Completion (India) |
03/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Pilot/Feasibility Study,
Prospective, Single-center, single arm with sequential enrollment for
Performance and Safety of MedTech Cochlear Implants in the treatment of
Severe-to-profound, sensorineural hearing loss in 3 patients from India.
Performance – To evaluate preoperative to 3 month’s
post-activation performance outcomes in the best unilateral listening condition.
Safety – Report of medical/surgical and
device related adverse events with regard to type, frequency and seriousness at
3 months’ post activation.
|