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
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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 StudyMinimally 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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- ••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.
排除标准
- ••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.
研究者
Vikram Singh Boparai
Tata Memorial Center