| CTRI Number |
CTRI/2024/11/077004 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [cochlear Implant ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pivotal Clinical Trials of HCL SUNO Cochlear Implant system to evaluate hearing performance in Indian population (Adult & Children) with a condition of severe to profound hearing loss |
|
Scientific Title of Study
|
Implantation with the HCL Suno/MedTech Cochlear Implant System in Adults and Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCL/Pivotal/I180074/2023, dated 11-OCT-2023, Version 1.0 |
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 |
Senior Professor room no 1
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 |
Operations Director – R&D ERS-MEDTECH Division |
| Affiliation |
HCL TECHNOLOGIES LIMITED |
| Address |
(AMB-6),
ODC- 401, Seat No: 00-04-401-M-02,
8 MTH Road, Ambattur Industrial Estate, Ambattur, Chennai 600058, INDIA
Chennai
TAMIL NADU
600058
India |
| Phone |
9840943236 |
| Fax |
|
| Email |
kalirajanb@hcltech.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalirajan Bose |
| Designation |
Program Manager Engineering R D |
| Affiliation |
HCL Technologies Limited |
| Address |
AMB 6 8 MTH Road Industrial Estate Ambattur
Chennai
TAMIL NADU
600058
India |
| Phone |
9840943236 |
| Fax |
|
| Email |
kalirajanb@hcltech.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HCL TECHNOLOGIES LIMITED |
| Address |
(AMB-6), 8 MTH Road, Ambattur Industrial Estate, Ambattur, Chennai 600058, INDIA |
| Type of Sponsor |
Other [Indian Multinational Information Technology Services and Consulting Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alok Thakar |
All India Institute of Medical Sciences |
Old OT Block, Room No.102, Ansari Nagar, New Delhi, Delhi - 110029
New Delhi
DELHI |
01126594862
drathakar@gmail.com |
| Dr Amit Goyal |
All India Institute of Medical Sciences (AIIMS), |
Basni Phase – II, Jodhpur Rajasthan – 342005
Jodhpur
RAJASTHAN |
8003996881
goyala@aiimsjodhpur.edu.in |
| Dr Sushil Kumar Aggarwal |
Banaras Hindu University |
Institute Of Medical Sciences, Banaras Hindu University Aurobindo Colony
Bhelupur
221005
Varanasi
UTTAR PRADESH |
7275721672
doc.sushil.pgi@gmail.com |
| 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 |
| Dr Oshin Thomas |
Brains Super Speciality Hospital |
192, T Mariyappa Road, Lalbagh, Siddapura,
Jayanagar 1st Block, Bengaluru - 560011,
Karnataka India
Bangalore
KARNATAKA |
9496576276
droshinent@gmail.com |
| Dr K R Meghanath |
MAA ENT Hospital |
Road No. 36, Jubilee Hills
Hyderabad
TELANGANA |
04023212166
drmegh@yahoo.com |
| Dr Sanjeev Mohanty |
MGM Healthcare Pvt Ltd |
No 126, BNT Connections Building, 4th Floor, Nelson Manickam Road, Aminjikarai, 600029
Chennai
TAMIL NADU |
9791074677
drsanjeevmohanty@gmail.com |
| Dr Anand Raju |
PSG institute of medical science and research |
Peelamedu, Coimbatore, Tamil Nadu - 641 004
Coimbatore
TAMIL NADU |
9842996596
ranandent@gmail.com |
| Dr Subba Rayadu |
R.R. Specialty Hospital |
13-3- 32, 3rd Line, Gunturuvarithota, Guntur, Andhra Pradesh – 522001
Guntur
ANDHRA PRADESH |
9603911777
ysrayudu@gmail.com |
| Dr Amit Keshri |
Sanjay Gandhi Postgraduate Institute of M Sciences |
Raibareli Rd, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH |
7275721669
amitkeshri2000@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| IEC-ESH Endolife Speciality Hospitals Pvt.Ltd |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Basaveshwara Medical College |
Approved |
| Institutional Ethics Committee Institute of Medical Ssciences Institute of Medical Sciences Banaras Hindu University |
Approved |
| Institutional Ethics Committee - Brains Super Speciality Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE Sanjay Gandhi Postgraduate Institute of M Sciences |
Approved |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE All India Institute of Medical Sciences |
Approved |
| MAA Research Ethics Committee MAA Research Foundation |
Approved |
| MGM - IEC MGM HEALTHCARE PVT LTD |
Approved |
| The Chairman INSTITUTIONAL HUMAN ETHICS COMMITTEE PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
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 |
HCL Suno/MedTech Cochlear Implant System |
Cochlear Implant is an electronic device implanted into the inner ear to improve hearing perception. The device consists of Implant Unit and External Speech processor. The Implant Unit is implanted and the patient is given audio verbal therapy for hearing and speech training.
Duration of follow-up for trials
Adults:
4 Months/Per Subject (1 Month for Activation and 3 months Follow up period)
Children:
6 Months/Per Subject (1 Month for Activation and 5 month follow up period)
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults
1.18 years of age or older
2.Severe to profound, sensorineural hearing loss great then 70 dB, determined by pure tune at 500Hz, 1000Hz and 2000Hz
3.Postlingual candidates with severe or profound bilateral 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 at 60 dBA presentation level
5.Moderate to profound hearing loss in the low frequencies and profound (≥ 90 dB HL) hearing loss in the mid to high speech frequencies
Children
1.Profound bilateral hearing loss in prelingual Children 1years to 06 years. Profound, sensorineural hearing loss greater then 90 dB, determined by pure tune at 500Hz, 1000Hz and 2000Hz
2.Severe to profound bilateral hearing loss in Postlingual children 7years to 17 Years. Severe to profound, sensorineural hearing loss greater then 70 dB, determined by pure tune at 500Hz, 1000Hz and 2000Hz
3.Little or no benefit from appropriately fitted hearing aids, which is defined as
In younger children less then 4 years of age) A failure to reach developmentally appropriate auditory milestones (such as spontaneous response to name in quiet or to environmental sounds) measured using the Infant Toddler Meaningful Auditory Integration Scale or Meaningful Auditory Integration Scale or less then 20% correct on a simple open-set word recognition test (Multisyllabic Lexical Neighborhood Test) administered using monitored live voice (70 dB SPL)
In older children (Post Lingual) greater then 7 years of age) Scoring less then 12% on a difficult open-set word recognition test (Phonetically Balanced Kindergarten Test) or less then 30% on an open set sentence test (Hearing in Noise Test for Children) administered using recorded materials in the sound field (70 dB SPL)
|
|
| ExclusionCriteria |
| Details |
1. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
2.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.
3.Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway (audio Neuropathy Spectrum disorder).
4.Active middle-ear infection.
5.Tympanic membrane perforation.
6.Unwillingness or inability of the candidate to comply with all investigational requirements.
7.Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
8.Patients with recurrent episodes of bacterial meningitis
9.Any other Cochlear Implant
10.Pregnant women applicable only for adults
|
|
|
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 and 5 month’s) post activation performance outcomes in the best unilateral and or bilateral listening condition (based on Unilateral or Bilateral implantation) for the commonly expected outcome (Hearing and Speech Improvement) at the end of third month and fifth month
Effectiveness Is defined as clinical benefits of greater than 20 % points in terms of improvement at the end of study period when compared with preoperative performance
Safety Report of medical or surgical and device related adverse events with regard to type, frequency and seriousness at 3 months and 5 months post activation
|
Adults 4 months per subject
Children 6 months per subject |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a Pivotal Study, Prospective, Multicenter, Non-Randomized,
Non-Blinded, single arm study across INDIA including Government & Private
sector health care center for safety, performance and effectiveness associated
with HCL Suno/ MedTech Cochlear Implant System
Adults:
Performance
– To evaluate preoperative to 3 month’s post activation performance outcomes in
the best unilateral and/or bilateral listening condition (based on Unilateral
or Bilateral implantation) for the commonly expected outcome (Hearing and
Speech Improvement) at the end of third month
Safety
– Report of medical/surgical and device related adverse events with regard to
type, frequency and seriousness at 3 months and 5 months post activation
Effectiveness:
Is defined as clinical benefits of greater than 20 % points in terms of
improvement at the end of study period when compared with preoperative
performance.
Children:
Performance
– To evaluate preoperative to 5 month’s post activation performance outcomes in
the best unilateral and/or bilateral listening condition (based on Unilateral
or Bilateral implantation) for the commonly expected outcome (Hearing and
Speech Improvement) at the end of third month and fifth months.
Safety
– Report of medical/surgical and device related adverse events with regard to
type, frequency and seriousness at 3 months and 5 months post activation.
Effectiveness: Is defined
as clinical benefits of greater than 20 % points in terms of improvement at the
end of study period when compared with preoperative performance. |