| CTRI Number |
CTRI/2019/11/021968 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
15/12/2019 |
| 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 Indian Cochlear Implant system SRAVAN to evaluate for effectiveness in improving hearing in patients with severe to profound hearing loss |
|
Scientific Title of Study
|
Multi-centric clinical trials of SRAVAN Indian Cochlear Implant system indigenously developed by DRDO |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. MCT/Sravan/Version dated 03/09/2014 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MD VENKATESH |
| Designation |
VICE CHANCELLOR |
| Affiliation |
SIKKIM MANIPAL UNIVERSITY |
| Address |
Room no.1
O/o Vice Chancellor
SIKKIM MANIPAL UNVERSITY
5TH MILE
UPPER TADONG
GANGTOK
South
SIKKIM
737102
India |
| Phone |
|
| Fax |
|
| Email |
sumvenk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRIPATHY |
| Designation |
PROGRAM MANAGER |
| Affiliation |
SOCIETY FOR BIOMEDICAL TECHNOLOGY |
| Address |
Room no: 113
SBMT Division
DEBEL
ADE CAMPUS
BANGALORE
Bangalore
KARNATAKA
560075
India |
| Phone |
9845042719 |
| Fax |
|
| Email |
contact@sbmtindia.org |
|
Details of Contact Person
Public Query
|
| Name |
DR V BHUJANGA RAO |
| Designation |
ISRO CHAIR PROFESSOR & CHIEF DESIGNER |
| Affiliation |
NATIONAL INSTITUTE OF ADVANCED STUDIES |
| Address |
F22
ACADEMIC BLOCK
NIAS
IISC CAMPUS
BANGALORE
Bangalore
KARNATAKA
560012
India |
| Phone |
|
| Fax |
|
| Email |
vepcrew1@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SOCIETY FOR BIOMEDICAL TECHNOLOGY
DEBEL DRDO
ADE CAMPUS
BANGALORE 560075 |
|
|
Primary Sponsor
|
| Name |
SOCIETY FOR BIOMEDICAL TECHNOLOGY |
| Address |
DEBEL
ADE CAMPUS |
| Type of Sponsor |
Other [Registered Society] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PROF ALOK THAKAR |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Dept of Otorhinolaryngology & Head - Neck Surgery
AIIMS
ANSARI NAGAR
NEW DELHI
110029
South
DELHI |
9999755916
drathakar@gmail.com |
| DR SUNIL NARAYAN DUTT |
APOLLO HOSPITALS |
Department of Otolaryngology (ENT) & Head-Neck Surgery
Apollo Hospitals, Bannerghatta Road
Opposite IIM (B), BANGALORE 560 076, INDIA
Bangalore
KARNATAKA |
9900128981
sunildutt@hotmail.com |
| PROF MARY JOHN |
CHRISTIAN MEDICAL COLLEGE |
Department of ENT Unit-2,
General and Pediatric ENT- hearing, implant and airway clinics,
Christian Medical College,
VELLORE
632004
Vellore
TAMIL NADU |
04162282798
maryjohn@cmcvellore.ac.in |
| PROF NARESH PANDA |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION & RESEARCH |
Dept of Otolaryngology
PGIMER
SECTOR 12
CHANDIGARH
Chandigarh
CHANDIGARH |
01722756760
npanda59@yahoo.co.in |
| PROF A RAVI KUMAR |
SRI RAMACHANDRA MEDICAL COLLEGE |
Dept of ENT
PORUR
CHENNAI
Chennai
TAMIL NADU |
09840433002
arunachalamravikumar1954@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IECCS APOLLO BANGALORE |
Approved |
| INSTITUTE ETHICS COMMITTEE AIIMS |
Approved |
| INSTITUTE ETHICS COMMITTEE PGIMER |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Approved |
| INSTITUTIONAL REVIEW BOARD CMC VELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COCHLEAR IMPLANT |
Cochlear Implant is an electronic device implanted into the inner ear to improve hearing perception. The device consists of Implantable Receiver Stimulator (IRS) and External Speech processor. The IRS is implanted and the patient is given audio verbal therapy for hearing and speech training. Duration of followup for trials is 2 years while the implant is designed to have life of 25 years. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
INDIVIDUALS WITH PRE-LINGUAL OR POST-LINGUAL SEVERE TO PROFOUND SENSORI-NEURAL HEARING LOSS WITH NO BENEFIT FROM HEARING AIDS |
|
| ExclusionCriteria |
| Details |
1. DEAFNESS DUE TO LESIONS OF ACOUSTIC NERVE OR OF CENTRAL AUDITORY PATHWAY
2. ABSENCE OF COCHLEAR DEVELOPMENT OR ABNORMAL COCHLEAR ANATOMY
3.ABSENCE OF COCHLEAR NERVE ON MRI
4. TYMPANIC MEMBRANE PERFORATIONS AND ACTIVE MIDDLE EAR INFECTIONS
5. POST MENINGITIS COCHLEAR OSSIFICATION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
IMPROVEMENT IN HEARING
IMPROVEMENT IN SPEECH PERCEPTION
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IMPROVED OVERALL COMMUNICATION ABILITY
IMPROVED CONFIDENCE AND SOCIAL INTERACTIONS |
24 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/11/2019 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sensory neural hearing loss is a major clinical problem encountered in pediatric and adult population. Cochlear implantation is now an established and well accepted mode of rehabilitation of profound deaf around the world. However due to high cost of implant many patients are unable to afford it. An indigenous affordable cochlear implant system has been developed under the aegis of society for biomedical technology to benefit the needy population. The device needs to be subjected to multi-centric human trials to evaluate safety and efficacy in subjects with profound sensoryneural hearing loss. The primary outcome in terms of improvement in hearing and speech development will be measured during the followup period. |