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CTRI Number  CTRI/2026/02/102666 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Mizzo Surgical Robotic System 
Scientific Title of Study   A Prospective, observational, single-arm, open-label, single-center clinical experience study to evaluate the MIZZO ENDO 4000 Robotic System. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Senthilnathan P 
Designation  Director and Head, Department of HPB and Minimal Access surgery 
Affiliation  Gem Hospital 
Address  Gem Hospital,MGR Salai, Perungudi, Chennai 600096

Chennai
TAMIL NADU
600096
India 
Phone  9500590573  
Fax    
Email  senthilnathan94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Senthilnathan P 
Designation  Director and Head, Department of HPB and Minimal Access surgery 
Affiliation  Gem Hospital 
Address  Gem Hospital,MGR Salai, Perungudi, Chennai 600096


TAMIL NADU
600096
India 
Phone  9500590573  
Fax    
Email  senthilnathan94@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Senthilnathan P 
Designation  Director and Head, Department of HPB and Minimal Access surgery 
Affiliation  Gem Hospital 
Address  Gem Hospital,MGR Salai, Perungudi, Chennai 600096


TAMIL NADU
600096
India 
Phone  9500590573  
Fax    
Email  senthilnathan94@gmail.com  
 
Source of Monetary or Material Support  
Gem Hospital Chennai  
 
Primary Sponsor  
Name  Gem Hospital 
Address  Gem Hospital, MGR Salai, Perungudi, Chennai -600096 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Senthilnathan P  Gem Hospital   MGR Salai, Perungudi, Chennai -600096 Department of HPB Surgery
Chennai
TAMIL NADU 		 9500590573

senthilnathan94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education Institutional Human Ethics Committee For Faculty Research (CARE IHEC-11)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 and undergoing cholecystectomy, antireflux surgery, HPB surgery, upper GI surgery, colorectal surgery, hernia (abdominal and inguinal)and solid cancer surgery 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 (e.g., severe cardiopulmonary diseases which contraindicated to general anesthesia, etc.)
5. Participants requiring urgent surgery.
6. Previous abdominal surgery (open or laparoscopic) 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 (e.g., mentally incompetent, alcohol or drug abuse) 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
3. Blood Loss 		 1. Time Frame: Intra-operative
2. Time Frame: Postoperative to Discharge
3. Time Frame: Intra-Operative 
 
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.SURG-TLX
9. Docking Time 		 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. Surgery Task Load Index
9. Time Frame: Intra-operative 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/02/2026 
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   Title: MIZZO ENDO 4000 Study
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.
Protocol ID, Version & Date: MIZZO ENDO 4000 IIS_Version 1.0.0_03-Jul-2025
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.
 
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