| CTRI Number |
CTRI/2025/11/097429 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MIZZO Advanced Surgical Robotic System |
|
Scientific Title of Study
|
A prospective, single-arm, open-label, single-center, Observational, study to evaluate the feasibility and performance of the MIZZO Robotic System in real world settings |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Mizzo IIS-1 V1.0.0 dated 04.Oct.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeshkumar P Shrivastava |
| Designation |
Director |
| Affiliation |
Shreeji Hospital |
| Address |
Shreeji Hospital Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105
Valsad
GUJARAT
396105
India |
| Phone |
9925029477 |
| Fax |
|
| Email |
dr.rajeshshree70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshkumar P Shrivastava |
| Designation |
Director |
| Affiliation |
Shreeji Hospital |
| Address |
Shreeji Hospital Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105
GUJARAT
396105
India |
| Phone |
9925029477 |
| Fax |
|
| Email |
dr.rajeshshree70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeshkumar P Shrivastava |
| Designation |
Director |
| Affiliation |
Shreeji Hospital |
| Address |
Shreeji Hospital Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105
GUJARAT
396105
India |
| Phone |
9925029477 |
| Fax |
|
| Email |
dr.rajeshshree70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shreeji Hospital Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105 |
|
|
Primary Sponsor
|
| Name |
Shreeji Hospital |
| Address |
Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Rajeshkumar P Shrivastava |
Shreeji Hospital |
Department of Laparoscopy, Ground floor, Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105
Valsad
GUJARAT |
9925029477
dr.rajeshshree70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dixit Hospital Institutional Ethics Committee |
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 of age 18 and above, irrespective of gender, undergoing laparoscopic surgery.
2.The participants who are willing to be treated with the Mizzo 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.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="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)
|
10/12/2025 |
| 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) |
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
|
Study Name: A prospective, observational, single-arm, open-label, single-center study to evaluate the feasibility and performance of the MIZZO Robotic System in real world settings.
Short Title: MIZZO Study
Objective: To evaluate the feasibility and performance of MIZZO.
Study Design: A prospective, observational, single-arm, open-label, single-center study.
Study Population: The study includes all consecutive participants who require the MIZZO is an Advanced Surgical Robotic System for laparoscopic surgery.
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 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 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 in routine surgical practice. |