| CTRI Number |
CTRI/2020/12/029746 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post Market Clinical Follow Up Investigation of Intraskan DC |
|
Scientific Title of Study
|
A prospective, post market, non-interventional observational, open label, single arm, single center study to validate the clinical safety and performance of Intraskan DC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 23-Nov-2020 |
Other |
| PLN-000692-0-20 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaishankar H P |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, JSS Dental College & Hospital,
Sri Shivarathreeshwara Nagara, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9448106487 |
| Fax |
|
| Email |
drjaishankarhp_dch@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaishankar H P |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, JSS Dental College & Hospital,
Sri Shivarathreeshwara Nagara, Mysore
KARNATAKA
570015
India |
| Phone |
9448106487 |
| Fax |
|
| Email |
drjaishankarhp_dch@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhara R |
| Designation |
Head- Regulatory Affairs |
| Affiliation |
Skanray Technologies Pvt Ltd |
| Address |
Department of Regulatory Affairs
Skanray Technologies Pvt Ltd Plot 15 16 17 Hebbal Industrial Area Mysore
Mysore
KARNATAKA
570016
India |
| Phone |
9844761818 |
| Fax |
|
| Email |
vasundhara.r@skanray.com |
|
|
Source of Monetary or Material Support
|
| Skanray Technologies Pvt Ltd Plot 15 16 17 Hebbal Industrial Area Mysore 570016 |
|
|
Primary Sponsor
|
| Name |
Skanray Technologies Pvt Ltd |
| Address |
Plot 15 16 17 Hebbal Industrial Area Mysore 570016 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
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 Jaishankar H P |
JSS Dental College and Hospital |
Department of Oral Medicine and Radiology, JSS Dental College & Hospital,
Sri Shivarathreeshwara Nagara, Mysore
Mysore
KARNATAKA |
9448106487
drjaishankarhp_dch@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee JSS Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects of all age groups.
Subjects or legally authorized representatives or guardians on behalf of the subject who are able and willing to provide written informed consent to participate in this clinical investigation.
|
|
| ExclusionCriteria |
| Details |
Pregnant or suspected to be pregnant based on the opinion of a physician.
Infant of age less than 1 year. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Collection of feedback which includes investigator’s assessment of the overall safety and performance of the devices Intraskan DC found to be appropriate to meet the predefined objectives. |
Within 14 days after capturing the radiographic
images. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Collection of feedback from the investigator on the radiographic images collected during the study and usability. This shall meet the predefined objectives to prove the claimed performance of Intraskan DC |
Within 14 days after capturing the radiographic images. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a post market clinical follow up investigation to validate the safety and performance of Intraskan DC. |