| CTRI Number |
CTRI/2015/12/006445 [Registered on: 17/12/2015] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study for a new minimally invasive system to treat chronic sinusitis |
|
Scientific Title of Study
|
A preliminary feasibility study to establish safety and efficacy of a Sinucare designed to perform balloon assisted sinus dilation (BSD) in Chronic Rhino sinusitis (CRS) Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagdish Chaturvedi |
| Designation |
Co-cordinator |
| Affiliation |
InnAccel Acceleration Services |
| Address |
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR
Bangalore
KARNATAKA
560025
India |
| Phone |
9650928582 |
| Fax |
|
| Email |
jagdishc@innaccel.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Chaturvedi |
| Designation |
Co-cordinator |
| Affiliation |
InnAccel Acceleration Services |
| Address |
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR
Bangalore
KARNATAKA
560025
India |
| Phone |
9650928582 |
| Fax |
|
| Email |
jagdishc@innaccel.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagdish Chaturvedi |
| Designation |
Co-cordinator |
| Affiliation |
InnAccel Acceleration Services |
| Address |
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR
Bangalore
KARNATAKA
560025
India |
| Phone |
9650928582 |
| Fax |
|
| Email |
jagdishc@innaccel.com |
|
|
Source of Monetary or Material Support
|
| Sponsor- InnAccel Acceleration Services Private Limited. AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR, BANGALORE - 560025, Karnataka INDIA |
|
|
Primary Sponsor
|
| Name |
InnAccel Acceleration Services |
| Address |
AANAND TOWERS MUNICIPAL NO.4, RAJARAM MOHAN ROY ROAD,WARD N0 77,SAMPANGIRAMANAGAR |
| Type of Sponsor |
Other [Private 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 Balasubramanya AM |
St. Johns Medical College Hospital |
St. John’s Medical College Hospital,
Department of ENT, Sarjapur Road, Bangalore, 560034
Bangalore
KARNATAKA |
9341229263
balaam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ST. JOHN’S NATIONAL ACADEMY OF HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Rhinosinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
none |
none single arm feasibilty study |
| Intervention |
SinuCare |
Investigational Device under development. Affordable minimally invasive sinus dilation system |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients must be between 18 – 60 years of age (Both sexes).
• Patients advised for a nasal endoscopy as part of standard of care.
• Patient is hemodynamic stable with no bleeding disorders
• Patient or a legal representative of the patient must be able to give written consent for the study.
|
|
| ExclusionCriteria |
| Details |
Patients on oral anti-coagulation.
Patients on inotropic drugs.
Patients with bleeding disorders like hemophilia.
Unwilling/ Unable to consent patients.
• Patients with nasal polyposis
• Enrolled in another interventional ENT clinical study
• Grossly abnormal nasal anatomy that would not allow introduction of the Sinucare per doctor’s judgement.
Patients not co-operating with a standard endoscopic exam (excess movements, hysterics, needing restraints)
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objectives of the study are to:
• To establish the feasibility of Sinucare for use during nasal endoscopy procedures
• To demonstrate the safety of Sinucare for use in patients undergoing rigid nasal endoscopic procedures
• To demonstrate the efficacy of SInucare in being used to dilate the sinus ostia of paranasal sinuses. |
The outcomes will be assessed at the end of each of the three phases of the study. Monitoring will be done for each patient to note any adverse events or issues with the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes
• Assess the Sinucare for the usability by a single clinician in an outpatient setting
• To report any modifications required in Sinucare design arising from patient variabilities
|
Single encounter. Calculated as a value based on study population at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/01/2016 |
| 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) |
Other (Terminated) |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This feasibility study is designed to evaluate the safety and efficacy of a new medical device (Sinucare) for management of chronic rhinosinusitis. The intended use of Sinucare in final form is to perform minimally invasive sinus ostia dilation for patients suffering from chronic Rhinosinusitis. The system has a component (SinuGuide) that can attach to a standard rigid nasal endoscopy to facilitate the introduction of balloon catheters (SinuCath) inside sinus. |