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MIZZO Advanced Surgical Robotic System

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097429
Enrollment
40
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Shreeji Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.Surgical success rate 2.Postoperative complications 3.Blood LossTimepoint: 1.Time Frame: Intra-operative 2.Time Frame: Postoperative to Discharge 3.Time Frame: Intra-Operative

Secondary

MeasureTime frame
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 examinationsTimepoint: 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

Countries

India

Contacts

Public ContactDr Rajeshkumar P Shrivastava

Shreeji Hospital

dr.rajeshshree70@gmail.com9925029477

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026