| CTRI Number |
CTRI/2026/01/102243 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mizzo Endo 4000 Advanced Surgical Robotic System |
|
Scientific Title of Study
|
A prospective, observational, single arm, open label, single center study to evaluate the feasibility and performance of the MIZZO ENDO 4000 Robotic System in real world settings |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Mizzo Endo 4000 IIS-1 V.1.0.0 DATED 03-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikram Singh Boparai |
| Designation |
Head of Department |
| Affiliation |
Tata Memorial Center |
| Address |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center)Medicity, Plot no.1, New Chandigarh, Punjab 140901
Ludhiana
PUNJAB
140901
India |
| Phone |
7034635147 |
| Fax |
|
| Email |
VIKRAMSINGHBOPARAI@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikram Singh Boparai |
| Designation |
Head of Department |
| Affiliation |
Tata Memorial Center |
| Address |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center)Medicity, Plot no.1, New Chandigarh, Punjab 140901
PUNJAB
140901
India |
| Phone |
7034635147 |
| Fax |
|
| Email |
VIKRAMSINGHBOPARAI@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikram Singh Boparai |
| Designation |
Head of Department |
| Affiliation |
Tata Memorial Center |
| Address |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center)Medicity, Plot no.1, New Chandigarh, Punjab 140901
PUNJAB
140901
India |
| Phone |
7034635147 |
| Fax |
|
| Email |
VIKRAMSINGHBOPARAI@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center) |
| Address |
Medicity, Plot no.1, New Chandigarh, Punjab 140901 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Vikram Singh Boparai |
Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center) |
Department of oncology, Medicity, Plot no.1, New Chandigarh, Punjab 140901
Ludhiana
PUNJAB |
7034635147
VIKRAMSINGHBOPARAI@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| (Tata Memorial Center) Homi Bhabha Cancer Hospital and Research Centre |
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 |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
•Participants with confirmed diagnosis of solid cancer of age 18 and above, irrespective of gender.
•The participants who are willing to be treated with the Mizzo Endo 4000 Advanced Surgical Robotic System.
•Participants who require endoscopic surgeries.
•The participants, LAR must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
|
|
| ExclusionCriteria |
| Details |
•Participants with coagulation disorders.
•Participants with morbid obesity.
•Pregnant or lactating women.
•Participant with a considerable risk for laparoscopic surgery
•Participants requiring urgent surgery.
•Previous abdominal surgery within 2 years before enrolment.
•Concurrent participation in another clinical study that may confound study results.
•Participant has a condition that could compromise study compliance as determined by the investigator.
•Participants who are considered unsuitable to conduct the trial as determined by the investigator.
•Participants who are unwilling or unsuitable for postoperative instructions.
•The participant who is unwilling or unable to sign the Informed Consent Document.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Surgical success rate
2.Postoperative complications
|
1.Time Frame: Intra-operative
2 Time Frame: Postoperative to Discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Console time
2.Operative time
3.Postoperative pain
4.Length of Hospital Stay
5.Intraoperative complications
6.Surgeon satisfaction score
7.Docking task load
8.Docking Time
9.Laboratory examinations |
1.Time Frame: Intra-operative
2.Time Frame: Intra-operative
3.Time Frame: Postoperative, through discharge
4.Time Frame: Admission to discharge
5.Time Frame: Intra-operative
6.Time Frame: Postoperative
7.Time Frame: Intra-operative
8.Time Frame: Intra-operative
9.Time Frame: Preoperative, through discharge |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/01/2027 |
| 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)
|
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
|
Study Name: A prospective, observational, single-arm,
open-label, single-center study to evaluate the feasibility and performance of
the MIZZO ENDO 4000 Robotic System in real world settings.
Short Title: MIZZO ENDO 4000 Study Protocol ID, Version &
Date:MIZZO ENDO 4000 IIS_Version 1.0.0_03-Jul-2025 Study Device:Mizzo Endo 4000 Advanced
Surgical Robotic System Indication: The product is controlled
by a master-slave control system for minimally invasive instruments and used
for laparoscopic operations in surgical oncology. Rationale of the Study Minimally
invasive surgery (MIS) has become the standard of care across various surgical
specialties due to reduced postoperative pain, shorter hospital stays, and
quicker recovery times. Robotic-assisted surgery enhances MIS by offering
improved dexterity, precision, and visualization. The MIZZO Endo 4000 Advanced
Surgical Robotic System is a next-generation platform designed to optimize
surgical performance through advanced ergonomics, multi-arm coordination, and
high-definition 3D imaging. However, clinical data evaluating its safety,
feasibility, and surgical outcomes across different specialties remain limited.
This study aims to assess the intraoperative performance, postoperative
recovery, and overall surgical success rates using the MIZZO Endo 4000 in lower
gastrointestinal, gynecological, and urological procedures. Key parameters
include operative time, console time, blood loss, complication rates, and
surgeon satisfaction. By capturing both objective surgical metrics and
subjective feedback, the study intends to provide a comprehensive evaluation of
the system’s effectiveness. The inclusion of a long-term follow-up phase will
also help assess sustained outcomes and potential late complications. The
findings will contribute essential clinical evidence to support the broader
adoption of the MIZZO Endo 4000 in routine surgical practice. |