| CTRI Number |
CTRI/2024/06/068361 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Remote telesurgery using Mantra Surgical robotic system. |
|
Scientific Title of Study
|
Remote telesurgery through a surgical-grade virtual private network
using Mantra Surgical robotic system. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SSI/2024/MANTRA_TELESURGERY_CIP/01 V 1.0 dated 14 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajneesh Kumar Mishra |
| Designation |
Director, World Laparoscopy Hospital |
| Affiliation |
World Laparoscopy Hospital |
| Address |
Division of Robotic Surgery, Department of Minimal Access Surgery, World Laparoscopy Hospital, Cyber City, DLF Cyber City, DLF Phase 2,
Sector 24
Gurgaon
HARYANA
122002
India |
| Phone |
9999677788 |
| Fax |
|
| Email |
md@laparoscopyhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Shokeen |
| Designation |
Head of Quality & Regulatory |
| Affiliation |
Sudhir Srivastava Innovations Pvt. Ltd. |
| Address |
Plot No. 404-405, 3rd Floor, iLabs Info Technology Centre, Phase-III, Udyog Vihar
Gurgaon
HARYANA
122016
India |
| Phone |
9958002162 |
| Fax |
|
| Email |
Sonia.shokeen@ssinnovations.org |
|
Details of Contact Person
Public Query
|
| Name |
Priyadarshini Arambam |
| Designation |
Director of Operations |
| Affiliation |
Clicebo Solutions Pvt. Ltd. |
| Address |
Clicebo Solutions Pvt. Ltd. E-961, Lower Ground Floor (Basement), C.R. Park,
South
DELHI
110019
India |
| Phone |
9910990347 |
| Fax |
|
| Email |
priyadarshini@clicebo.com |
|
|
Source of Monetary or Material Support
|
| Sudhir Srivastava Innovations Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Sudhir Srivastava Innovations Pvt Ltd |
| Address |
Plot No. 404-405, 3rd Floor, iLabs Info Technology
Centre, Phase-III, Udyog Vihar, Gurugram, Haryana, India – 122016 |
| Type of Sponsor |
Other [Medical Device 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 Rajneesh Kumar Mishra |
World Laparoscopy Hospital |
Room No-1, Division of Robotic Surgery, Department of Surgery, Cyber City, DLF Cyber City, DLF Phase 2, Sector 24, 122002
Gurgaon
HARYANA |
9999677788
md@laparoscopyhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
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 |
Mantra Surgical robotic system Model 2.0 |
Remote telesurgery used in conditions for:
Cholecystectomy: Total surgery time 1.5Hrs
Inguinal Hernia Repair: Total surgery time 2.5Hrs
Ventral Hernia Repair: Total surgery time 2.5Hrs
Appendectomy: Total surgery time 1.5Hrs
Ovarian Cystectomy: Total surgery time 1Hrs
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or Female patients with age of eighteen (18) and above.
Able to give written informed consent.
Patients meeting the inclusion criteria for general surgery such as the following surgical procedures using multi-arm robotic system for soft tissue surgeries:
Cholecystectomy
Inguinal Hernia Repair
Ventral Hernia Repair
Appendectomy
Ovarian Cystectomy |
|
| ExclusionCriteria |
| Details |
Patients who have participated in another investigational clinical study within thirty (30) days before screening
Inability to provide informed consent
Uncontrolled hypertension, diabetes mellitus or any other co- morbidity that is considered as a high risk for the planned surgical procedure
Patients who fall into New York Heart Association (NYHA) Class III or IV
History of chronic alcohol or drug abuse.
Chronic renal failure or on dialysis.
Subjects with any other clinically significant unstable medical condition, life-threatening disease, or anything else in the opinion of the Investigator that would contra-indicate a surgical procedure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
System tasks required for execution of the predefined procedures was feasible without impacting safety and performance.
Latency did not interfere with the execution of predefined procedures.
No interruptions due to Network Bandwidth and/ or stability.
Device related adverse events. |
Procedure (Visit 2)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Data packet loss
Cybersecurity measures- Data Encryption & Data Integrity
Operative time – from incision to skin closure
Blood loss during the surgery
Length of hospital stay
Return to the operating room within 24 hours of surgery
Rate of hospital readmission after discharge (Noted during the entire duration of the study)
Ease of the system by surgeons & operating
Adverse events during the follow-up period per protocol. |
Visit 3, Visit 4 & Visit 5 |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
08/06/2024 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 is a prospective data collection, non-randomized, single centre study to assess the capability of remote telesurgery to perform accurate surgical procedures using MantraTM surgical robotic system, Model 2.0. Remote telesurgery will be established using secure network via multi-protocol label switching (MPLS).
The study shall be done with a total number of five (5) patients that meet the criteria for inclusion.
The study duration is expected to be approximately two (2) months.
The study comprises of following visits: • Screening Visit (Visit 1) • Day of Surgery (Visit 2) • Day of Discharge (Visit 3) • Follow Visit (Visit 4) • End of study Visit (Visit 5)
A pilot clinical study was already conducted on this device with the CTRI number: CTRI/2020/11/029053. It was done as hospital based surgery and now it is design for pilot study in telesurgery mode and rest objective are same Powered by |