| CTRI Number |
CTRI/2024/06/068556 [Registered on: 06/06/2024] 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
|
MantraTM Surgical Robotic System, Model 3.0 - Interventional Clinical Study for 10 patients. |
|
Scientific Title of Study
|
A prospective non-randomised pilot clinical study to evaluate the safety, feasibility, and efficacy of MantraTM Surgical Robotic System, Model 3.0 in the predetermined surgical procedures. |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SSI/2024/MANTRA 3.0_Pilot Study_CIP/01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prof Sudhir Kumar Rawal |
| Designation |
Medical Director and Chief of GenitoUro - Oncology Services |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Room No-3177, First Floor, D-Block, Sector-5, Rohini
New Delhi 110085
New Delhi
DELHI
110085
India |
| Phone |
9810139757 |
| Fax |
91-11-27051037 |
| Email |
sudhirrawal85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Srivastava |
| Designation |
Founder, Chairman, and CEO |
| Affiliation |
Sudhir Srivastava Innovations Pvt. Ltd. |
| Address |
Plot No. 404-405, 3rd Floor, iLabs Info Technology Centre, Phase-III, Udyog Vihar, Gurugram,
Gurgaon
HARYANA
122016
India |
| Phone |
8912744440 |
| Fax |
|
| Email |
sudhir.srivastava@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
South
DELHI
110019
India |
| Phone |
9910990347 |
| Fax |
|
| Email |
priyadarshini@clicebo.com |
|
|
Source of Monetary or Material Support
|
| Sudhir Srivastava Innovations Pvt. Ltd, Plot No. 404-405, 3rd Floor, iLabs Info Technology Centre, Phase-III, Udyog Vihar, Gurugram, Haryana, India – 122016
|
|
|
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 Sudhir Kumar Rawal |
Rajiv Gandhi Cancer Institute and Research Centre |
Room No-3177, First Floor, D-Block, Sir Chotu Ram Marg, Sector - 5, Rohini Industrial Area, Rohini, New Delhi - 110085
New Delhi
DELHI |
9810139757
91-11-27051037
sudhirrawal85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
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 |
MantraTM Surgical Robotic System, Model 3.0 |
Robotic surgery used in conditions for:
i. Cholecystectomy
ii. Hysterectomy
iii. Nephrectomy
iv. Prostatectomy
v. Oesophagus mobilization
vi. Internal Mammary Artery
takedown
vii. Cystectomy
viii. Lung Lobectomy
ix. Nephron Sparing Surgery
x. Bilateral Pelvic Lymph Node
Dissection
xi. Radical Cystoprostatectomy
xii. Partial Nephrectomy
|
| 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 one of the following surgical procedures using MantraTM Surgical Robotic System, Model 3.0 for soft tissue surgeries:
Cholecystectomy
Hysterectomy
Nephrectomy
Prostatectomy
Oesophagus mobilization
Internal Mammary Artery takedown
Cystectomy
Lung Lobectomy
Nephron Sparing Surgery
Bilateral Pelvic Lymph Node Dissection
Radical Cystoprostatectomy
Partial Nephrectomy |
|
| ExclusionCriteria |
| Details |
Patients who have participated in another investigational clinical study within thirty (30) days before screening
Inability to provide informed consent
Uncontrolled Comorbidities such as hypertension, diabetes mellitus or any other co-morbidities 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 could be performed safely on predefined
procedures.
System tasks required for the performance of predetermined
procedures.
System tasks required are feasible and could be carried out
effectively.
Device related adverse events. |
Procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of the system by surgeons and operating room staff.
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)
Adverse events during the follow-up period per protocol.
|
Post Procedure till End of Study |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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, pilot clinical study to assess the capability of MantraTM Surgical Robotic System, Model 3.0 to perform accurate surgical procedures. The study shall be carried out at a single centre with total number of ten (10) patients that meet the criteria for inclusion. The study duration is expected to be approximately two (2) months. Meeting the inclusion criteria using MantraTM Surgical Robotic System, Model 3.0.
The study comprises of following visits: Screening Visit (Visit 1) Day of Surgery (Visit 2) Day of Discharge (Visit 3) Follow Visit (Visit 4)s End of study Visit (Visit 5)
This study is registered with CTRI Number CTRI/2020/11/029053
|