| CTRI Number |
CTRI/2025/02/081197 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Participants will be enrolled in a Post Market Clinical Study where the safety and performance of skanrays anesthetic workstations will be evaluated |
|
Scientific Title of Study
|
Post Market Clinical Study of Skanrays Anesthetic Workstations - SkanSiesta Pro |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3-75-010-0118-12 Version 01 Date 03 October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VY Srinivas |
| Designation |
Head of the department - Anesthesia |
| Affiliation |
Krishna Rajendra Hospital, Mysore |
| Address |
Department of anesthesia Krishna Rajendra Hospital Irwin Rd Devaraja Mohalla
Yadavagiri Mysuru Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9448165082 |
| Fax |
|
| Email |
drsrinivasvy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Krishna Rajendra Hospital, Mysore |
| Address |
Department of anesthesia Krishna Rajendra Hospital Irwin Rd Devaraja Mohalla
Yadavagiri Mysuru Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
8088705464 |
| Fax |
|
| Email |
viveknayak007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhara R |
| Designation |
Head - Regulatory affaris |
| Affiliation |
Skanray Technologies Limited |
| Address |
Department of regulatory affairs
Skanray Technologies Limited Plot #15-17 Hebbal Industrial Area Mysore Karnataka
Mysore
KARNATAKA
570016
India |
| Phone |
9844761818 |
| Fax |
|
| Email |
vasundhara.r@skanray.com |
|
|
Source of Monetary or Material Support
|
| Skanray Technologies Limited
Plot #15-17 Hebbal industrial area Karnataka Mysore
India 570016 |
|
|
Primary Sponsor
|
| Name |
Skanray Technologies Limited |
| Address |
Plot # 15-17, Hebbal Industrial Area, Mysore 570016 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Skanray Technologies Limited |
Plot # 15-17, Hebbal Industrial Area, Mysore 570016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VY Srinivas |
Krishna Rajendra Hospital |
Department of anesthesia Krishna Rajendra Hospital Irwin Rd Devaraja Mohalla
Yadavagiri Mysuru Karnataka - 570001
Mysore
KARNATAKA |
9448165082
drsrinivasvy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Mysore Medical college and Research Institute and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult and pediatric subjects of age more than two year or body weight of 10 kg above whichever is lower and of either gender.The subjects belongs to the category of ASA1 physical status shall be included. (Note: ASA2 ASA3 ASA4 and ASA5 classified physical status subjects shall be included after the completion of the
pilot phase).Subject or the legally authorized representative on behalf of the
subject shall be capable of understanding and signing the informed consent form |
|
| ExclusionCriteria |
| Details |
Subjects with age less than two year or less than 10 kg of body
weight.Pregnant population shall be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the adequate patient oxygenation,ventilation and delivery of anesthetic gas mixtures in accordance with need of the subjectsthroughout the surgery. Determining the performance in terms of delivered parameters against the intended or set values for the specific subject condition. Determine the possible unknown adverse events,undesirable side effects associated with use of the device. |
For 60 minutes surgery: 0,12,24,36,48,60th
minute.
For 120 minutes surgery: 0,24,48,72,96,120th
minute.
For 360 minutes surgery: 0, 36,72,108,144,180
minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the patient reported outcomes from user,collection of feedback from user and investigator |
7days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Skanrays Anesthetic Workstations are continous use anesthetic workstations which are used to deliver anesthesia and provide mechanically or spontaneously induced ventilation to the adult and pediatric patients. It is capable of providing air oxygen N2O as mixture with anesthetic agents at set parameters. The purpose of this study is to confirm the clinical safety and performance of Skanrays anesthetic workstations. This study will generate the clinical evidence to support the claimed intended use.
|