| CTRI Number |
CTRI/2025/11/097272 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| 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 Version 1.0.0 03-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surender Kumar Dabas |
| Designation |
Chairman |
| Affiliation |
Manipal Hospital |
| Address |
Comprehensive Cancer Centre and Onco Robotic Surgeries, Manipal Hospital,Sector 6 Dwarka, Dwarka, Delhi, 110075 India
New Delhi DELHI 110075 India |
| Phone |
9868466333 |
| Fax |
|
| Email |
surenderdabas318@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Surender Kumar Dabas |
| Designation |
Chairman |
| Affiliation |
Manipal Hospital |
| Address |
Comprehensive Cancer Centre and Onco Robotic Surgeries, Manipal Hospital,Sector 6 Dwarka, Dwarka, Delhi, 110075 India
DELHI 110075 India |
| Phone |
9868466333 |
| Fax |
|
| Email |
surenderdabas318@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Surender Kumar Dabas |
| Designation |
Chairman |
| Affiliation |
Manipal Hospital |
| Address |
Comprehensive Cancer Centre and Onco Robotic Surgeries, Manipal Hospital,Sector 6 Dwarka, Dwarka, Delhi, 110075 India
DELHI 110075 India |
| Phone |
9868466333 |
| Fax |
|
| Email |
surenderdabas318@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Hospital |
| Address |
Sector 6 Dwarka, Dwarka, Delhi, 110075 India |
| 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 |
| Dr Surender Kumar Dabas |
Manipal Hospital |
First Floor, OPD 1, Manipal Hospital Sec-6, Palam Vihar Rd, Sector 6 Dwarka, Dwarka, New Delhi, Delhi, 110075 New Delhi DELHI |
9868466333
surenderdabas318@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Care Medical Charitable Trust |
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 |
1. Participants with confirmed diagnosis of solid cancer of age 18 and above, irrespective of gender.
2. The participants who are willing to be treated with the Mizzo Endo 4000 Advanced Surgical Robotic System.
3. Participants who require endoscopic surgeries.
4. 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 |
1.Participants with coagulation disorders.
2.Participants with morbid obesity.
3.Pregnant or lactating women.
4.Participant with a considerable risk for laparoscopic surgery
5.Participants requiring urgent surgery.
6.Previous abdominal surgery within 2 years before enrolment.
7.Concurrent participation in another clinical study that may confound study results.
8. Participant has a condition that could compromise study compliance as determined by the investigator.
9. Participants who are considered unsuitable to conduct the trial as determined by the investigator.
10. Participants who are unwilling or unsuitable for postoperative instructions.
11. 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: Intraoperative
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="70" Sample Size from India="70"
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)
|
30/11/2025 |
| 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="0" Days="10" |
|
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: MIZZO ENDO 4000 Study
Study Title: 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.
Study Device: Mizzo Endo 4000 Advanced Surgical Robotic System
Objective: To evaluate the feasibility and performance of MIZZO ENDO 4000.
Study Design: A prospective, observational, single-arm, open-label, single-center
study.
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. |